MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-16 for ARTIFICIAL URINARY SPHINCTER CUFF 72404130 manufactured by American Medical Systems, Inc..
[19363157]
Ams was notified on (b)(4) 2011, the entire device was replaced on (b)(6) 2011 (reported on q3 asr) the reason for replacement was not provided. Add'l info on (b)(4) 2011, stated the reason for removal was due to "urethral laceration" and the pt outcome was "revision on (b)(6) 2011. " ams requested add'l info to clarify the events and determine the cause of the urethral laceration but no updates have been provided.
Patient Sequence No: 1, Text Type: D, B5
[19380849]
If add'l info becomes available regarding this event, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2011-00644 |
| MDR Report Key | 2386574 |
| Report Source | 05 |
| Date Received | 2011-12-16 |
| Date of Report | 2011-09-16 |
| Date of Event | 2011-09-14 |
| Date Mfgr Received | 2011-09-16 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2011-12-23 |
| 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 | JON CORNELL, SR., MGR. |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306670 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTIFICIAL URINARY SPHINCTER |
| Generic Name | AMS 800 |
| Product Code | FAG |
| Date Received | 2011-12-16 |
| Model Number | CUFF |
| Catalog Number | 72404130 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-12-16 |