Navigation Links
Federal Agents Seize FastSize Extenders and FastSize EQM™ Erectile Quality Monitors

Unapproved devices are adulterated and misbranded; safety and efficacy not established

SILVER SPRING, Md., July 27 /PRNewswire-USNewswire/ -- 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 Peyronie's disease. Because the devices are intended to diagnose, 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.

For more information:

FDA: Inspections, Compliance, Enforcement, and Criminal Investigations

Media Inquiries: Erica Jefferson, 301-796-4988,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Federal Appeals Court Rules Pharmaceutical Sales Reps Entitled to Overtime Pay
2. St. Jude Medical and Hospitals in Ohio and Kentucky to Pay Almost $4 Million to Federal Government to Resolve Fraud Allegations
3. Total Federal Grant Funds for Indiana Health Information Technology Efforts Climb to Nearly $50 Million; Latest $16 Million Installment Spotlights Indiana Health Information Exchange in Delivering Higher Quality and Higher Value Healthcare Through M
4. Federal Aviation Administration Selects Partners For Nationwide AED Program
5. Chesley Files Federal Zicam Lawsuits
6. Federal Judge Rejects GlaxoSmithKlines Claims of Privilege
7. Malaria Experts Call on Federal Government to Increase Support for Research and Development
8. Faced With Federal Prosecution, MountainView Agrees to Stop Harassment of RNs in Settlement With Labor Board
9. Childrens Hospital Receives Six-Year Federal Contract to Study Antibiotic Use in Children With Urinary Tract Infections
10. Southern Research to Play Key Role in the Federal Governments Search for New Cancer Therapies
11. Mars, Incorporated Commits Over $2 Million to Federal Agency for Human-Animal Interaction Research
Post Your Comments:
(Date:12/1/2015)... , December 1, 2015 ... Contraceptive Injectables, Topical Contraceptives, Male Condoms, Female ... Vaginal Rings, Contraceptive Diaphragms, Contraceptive Sponges, Non-Surgical ... Size, Share, Growth, Trends and Forecast 2014 ... Transparency Market Research (TMR).The report states that ...
(Date:12/1/2015)... 1, 2015  InCarda Therapeutics, Inc. (InCarda), a privately-held ... therapies for cardiovascular conditions via the inhalation route, today ... Australia . InCarda is planning to ... Australia in the first half of 2016. ... centers in Adelaide and Melbourne.  ...
(Date:12/1/2015)... 2015 ) ... Alert Systems/Personal Emergency Response System (PERS) Market by ... Forecas" report to their offering. --> ... the "Medical Alert Systems/Personal Emergency Response System ... Geography - Global Forecas" report to their ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... Baptist Medical Center Jacksonville has ... the only hospital in the region providing what is known as the world’s ... patients were revealed recently at a medical conference and published in The New ...
(Date:12/1/2015)... TX (PRWEB) , ... December 01, 2015 , ... Dr. ... of Vitenas Cosmetic Surgery, has been named by MedEsthetics magazine as the Best Single ... of the best among the many elite aesthetic physicians honored by the industry publication. ...
(Date:12/1/2015)... ... December 01, 2015 , ... Growth in medical payments ... to decreases in utilization of hospital and nonhospital care, according to a recent study ... Benchmarks for Louisiana, 16th Edition , found medical payments per claim with more than ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... ... the 1980s we have seen vast improvements in scientific research and discoveries, leading ... strides, providing increased hope and relief to those affected by HIV/AIDS. Mediaplanet’s cross-platform ...
(Date:12/1/2015)... ... , ... It’s official: Tattoo taboo is a thing of the past. One ... (a whopping one in three aged 18 to 25 is inked). As tattoos transition ... ink. In fact, RealSelf , the world’s largest community for learning and sharing ...
Breaking Medicine News(10 mins):