*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-26 for * manufactured by Augusta Medical Systems, Llc.

Event Text Entries

[17892644] On or about 01/26/05, my physician suggested and prescribed a vacuum erection system offered by augusta medical systems. I rec'd the product at the end of 01/05. The unit failed because augusta's design used a poor quality electric switch. I returned the "system" on 02/07/05 and rec'd a replacement about ten days later. I tried to use the product as dictated by the labeling and written and audio-visual instructions. The unit created several serious side effects, making it impossible to use. The physician advised me to discontinue the use of the device and i contacted augusta as required by their written instructions. I needed augusta's instructions for returning the system. Over time i discussed the problems with two co employees on the following dates: march 7 (2 times), march 8, july 5, july 6, july 7 (3 times). On july 7, i was assured that a refund of my payment would be made within two (2) weeks, that means about by 07/21/05. As of 08/16/05, i have not rec'd a refund or any communication from augusta. Their brochures advise that they would reimburse the customer and his insurance carrier(s), in this case medicare and blue shield supplemental plans. I believe that augusta is committing fraud, false advertising and misleading the fda by selling an "fda approved" sex toy that can be purchased from other suppliers for one fourth of augusta's charges.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1036564
MDR Report Key757794
Date Received2005-08-26
Date Added to Maude2006-09-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameVACUUM ERECTION SYSTEM
Product CodeLKY
Date Received2005-08-26
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key745694
ManufacturerAUGUSTA MEDICAL SYSTEMS, LLC
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2005-08-26

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