MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05 report with the FDA on 2012-12-05 for AMS SPHINCTER 800 URINARY PROSTHESIS 72404127 manufactured by American Medical Systems, Inc..
[3245227]
It was reported that the pump "was inserted in an upside down position" due to a "previous injury from 19 years ago that has influenced the surgical positioning" and that "scar tissue appears to be influencing the access to the pump as well. " it was also reported that the device "has not worked at all" and that the patient has "soreness and discomfort. " a "revision" was reported to have occurred on (b)(6) 2012. The reservoir and cuff were checked and the pump was replaced in the "down" position. The device was "fully operable and functioning well" at the end of the procedure. Additional information regarding the event has been requested, but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[10289008]
Should additional information become available regarding this event it will be re-evaluated and a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2012-03098 |
| MDR Report Key | 2871401 |
| Report Source | 01,04,05 |
| Date Received | 2012-12-05 |
| Date of Report | 2012-11-14 |
| Date of Event | 2012-09-19 |
| Date Mfgr Received | 2012-11-14 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2012-12-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON ZURN, DIRECTOR |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306347 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS SPHINCTER 800 URINARY PROSTHESIS |
| Generic Name | ARTIFICIAL URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2012-12-05 |
| Catalog Number | 72404127 |
| Device Expiration Date | 2013-07-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-12-05 |