MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-28 for AMS SPHINCTER 800 URINARY PROSTHESIS 72404127 manufactured by American Medical Systems, Inc..
[2994420]
Related to mfr report # 2183959-2012-02498. It was reported that subsequent to the implantation of an aus device and during the concomitant implant of a penile prosthesis reservoir, a main artery was perforated. The balloon and pump were removed and the cuff was left in place to avoid further extension of surgery time. The artery was repaired and the pt was given a blood transfusion. Attempts to obtain additional info have been unsuccessful - pt outcome and repair details were not provided.
Patient Sequence No: 1, Text Type: D, B5
[10011945]
Balloon catalog #72400024, serial (b)(4), exp 07/01/2017. The analysis results indicate the device performed within specifications. Should additional info become available regarding this event, it will be re-evaluated and a f/u report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2012-02499 |
| MDR Report Key | 2720559 |
| Report Source | 05 |
| Date Received | 2012-08-28 |
| Date of Report | 2012-08-01 |
| Date of Event | 2012-08-01 |
| Date Mfgr Received | 2012-08-01 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2012-09-04 |
| 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 | RANDY HOYT, SR. MGR. |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306277 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS SPHINCTER 800 URINARY PROSTHESIS |
| Generic Name | ARTIFICIAL URINARY SPHINCTER |
| Product Code | FAG |
| Date Received | 2012-08-28 |
| Returned To Mfg | 2012-08-07 |
| Catalog Number | 72404127 |
| Device Expiration Date | 2013-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-08-28 |