Home» Medical News

Federal Agents Seize FastSize Extenders and FastSize EQM Erectile Quality Monitors
Views: 94
Date: 28 Jul 2010
Definition of medical terminology for Devices.
Definition of medical terminology for Safety.
Unapproved devices are adulterated and misbranded; safety and efficacy not established

Definition of medical terminology for Food.
Definition of medical terminology for Devices.
Definition of medical terminology for Seizure.
Definition of medical terminology for District of Columbia.
Definition of medical terminology for Device.
Definition of medical terminology for Measure.
Definition of medical terminology for Diagnosis.
Definition of medical terminology for Health.
Definition of medical terminology for High Chair.
Definition of medical terminology for Heart.
Definition of medical terminology for Disease.
Definition of medical terminology for Device.
Definition of medical terminology for Overall.
Definition of medical terminology for Health.
Definition of medical terminology for Deformity.
Definition of medical terminology for Disease.
Definition of medical terminology for Devices.
Definition of medical terminology for Devices.
current good manufacturing practice
Definition of medical terminology for Regulations.
Definition of medical terminology for Devices.
Definition of medical terminology for Devices.
Definition of medical terminology for Medical Device.
Definition of medical terminology for Device.
Definition of medical terminology for Regulation.

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $346,954.43 worth of FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices, as well as component parts used in the manufacture of the FastSize Extender. The FastSize Extender and the FastSize EQM Erectile Quality Monitor are manufactured and distributed by FastSize, LLC of Aliso Viejo, Calif.


The FastSize Extender and the FastSize EQM Erectile Quality Monitor are misbranded and adulterated because they, among other things, are unapproved and were manufactured under conditions that did not meet current Good Manufacturing Practices (cGMP) requirements. The seizure warrant was issued by the U.S. District Court for the Central District of California.


The FastSize EQM Erectile Quality Monitor device was promoted to measure penile axial rigidity (intercavernosal pressure) and to aid in the diagnosis of health related issues such as diabetes, high blood pressure, and heart disease. The FastSize Extender device was promoted to gain length, girth, and overall penile health improvement and to correct penile deformity caused by Peyroniea€™s disease. Because the devices are intended to diagnosis, cure, mitigate, treat or prevent diseases, they are subject to the regulatory authority of the FDA.The devices do not have approved applications for premarket approval for these uses.


During a recent inspection of the FastSize LLC manufacturing facility, inspectors noted significant deviations from cGMP regulations. Additionally, the devices are not properly listed with the FDA as required by law, and the firm failed or refused to furnish materials or information regarding the devices to federal inspectors as required under the Medical Device Reporting regulation.


Source : DrugsFreeList.com
Tags: FastSize Extender

Latest Medical News

» U.S. Food And Drug Administration Approves Pfizer’s INLYTA (axitinib) For Patients With Previously Treated Advanced Renal Cell Carcinoma (RCC)
-Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved INLYTA® (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC)
29 Jan 2012 | Read


» Pfizer Announces FDA Acceptance Of New Drug Application For Bosutinib For Patients With Previously Treated Ph Chronic Myeloid Leukemia
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for standard review of bosutinib as a treatment option for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
29 Jan 2012 | Read


» FDA approves Inlyta to treat patients with a type of advanced kidney cancer
The U.S. Food and Drug Administration approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.
29 Jan 2012 | Read


» FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML).
29 Jan 2012 | Read


» FDA. New and Generic Drug Approvals - January 27, 2012
New drugs approved. List of drugs approved by FDA to date January 27, 2012
29 Jan 2012 | Read


» FDA. New and Generic Drug Approvals - January 26, 2012
New drugs approved. List of drugs approved by FDA to date January 26, 2012
29 Jan 2012 | Read


» FDA. New and Generic Drug Approvals - January 25, 2012
New drugs approved.List of drugs approved by FDA to date January 25, 2012
29 Jan 2012 | Read


» FDA. New and Generic Drug Approvals - January 24, 2012
New drugs approved. List of drugs approved by FDA to date January 24, 2012
29 Jan 2012 | Read


» FDA. New and Generic Drug Approvals - January 23, 2012
New drugs approved.List of drugs approved by FDA to date January 23, 2012
29 Jan 2012 | Read


» FDA. New and Generic Drug Approvals - January 20, 2012
New drugs approved. List of drugs approved by FDA to date January 20, 2012
29 Jan 2012 | Read


» FDA. New and Generic Drug Approvals - January 19, 2012
New drugs approved. List of drugs approved by FDA to date January 19, 2012
29 Jan 2012 | Read


» FDA. New and Generic Drug Approvals - January 18, 2012
New drugs approved. List of drugs approved by FDA to date January 18, 2012
29 Jan 2012 | Read


» FDA expands use of endovascular graft to treat aortic tears
The U.S. Food and Drug Administration expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection).
19 Jan 2012 | Read


» FDA approves Voraxaze to treat patients with toxic methotrexate levels
The U.S. Food and Drug Administration approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.
19 Jan 2012 | Read


» FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)
The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin).
19 Jan 2012 | Read


General Search

Last medical tags:


Torisel, temsirolimus, Inlyta, chronic myeloid leukemia, bosutinib, Inlyta, renal cell carcinoma, kidney cancer, myelin, Tysabri, natalizumab, brain infection, progressive multifocal leukoencephalopathy, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, thoracic aortic transection, endovascular graft, methotrexate, Voraxaze, cancer chemotherapy drug, glucarpidase, Adcetris, bleomycin, multifocal leukoencephalopathy, CardioGen-82, radiation, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, FDA, New drugs approval 2012, drugs approved by FDA, raltegravir, Isentress, antiretroviral medicines, Theravance, Relovair, asthma, fluticasone, bronchitis, neuromuscular disease, SMA, muscle atrophy, Resolor, prokinetic, prucalopride, ADHD, psychiatric behavioural disorder, Venvanse, lisdexamfetamine dimesylate, type 2 diabetes mellitus, Actoplus Met XR, pioglitazone, Mylan, Eprosartan Mesylate Tablets, Teveten, antimicrobials, cephapirin, cephalosporin, teriflunomide, Rebif, alanine aminotransferase levels, flu-like symptoms, multiple sclerosis, electrical pulses, implantable pulse generator, Precision Plus Spinal Cord Stimulator, genetic blood clotting disorder, hemophilia A, Advate, bleeding episodes, heart failure, heart transplantation, Pediatric Medical Device Safety, pulsatile cardiac assist device, selective serotonin reuptake inhibitor, SSRI, pulmonary hypertension,
» All tags  
Sitemap