MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-10-02 for ARTIFICIAL URINARY SPHINCTER 800 manufactured by American Medical Systems, Inc.
[27444]
The cuff was removed from the pt and replaced due to cuff was too big.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126328-1996-04501 |
| MDR Report Key | 41456 |
| Report Source | 05 |
| Date Received | 1996-10-02 |
| Date of Report | 1996-10-01 |
| Date of Event | 1996-07-16 |
| Date Mfgr Received | 1996-09-03 |
| Device Manufacturer Date | 1994-10-01 |
| Date Added to Maude | 1996-10-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTIFICIAL URINARY SPHINCTER |
| Generic Name | AUS |
| Product Code | FAG |
| Date Received | 1996-10-02 |
| Model Number | 800 |
| Catalog Number | NA |
| Lot Number | 1997M 010 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 42535 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC |
| Manufacturer Address | 10700 BREN RD WEST MINNETONKA MN 55343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-10-02 |