MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-06-22 for SPARC SLING SYSTEMS 72403656 NA manufactured by American Medical Systems, Inc..
[321185]
Ams received information that a pt who had a sparc sling system procedure had reported severe pain post-op. Several days post-op the doctor determined that he perforated the bowel when placing the sparc device. The pt had elevated temperature and pain. The sparc sling was removed and the bowel reanastomized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2004-00028 |
| MDR Report Key | 531203 |
| Report Source | 00 |
| Date Received | 2004-06-22 |
| Date of Report | 2004-06-21 |
| Date of Event | 2003-12-01 |
| Date Mfgr Received | 2004-05-24 |
| Date Added to Maude | 2004-06-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | THERESE BOWKER, MDR CONTACT |
| Manufacturer Street | 10700 BREN ROAD WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306624 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPARC SLING SYSTEMS |
| Generic Name | SPARC/OTHER SLING TYPES |
| Product Code | FHK |
| Date Received | 2004-06-22 |
| Model Number | 72403656 |
| Catalog Number | NA |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 520453 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US |
| Baseline Brand Name | SPARC SLING SYSTEM |
| Baseline Generic Name | SPARC SLING SYSTEM |
| Baseline Model No | 72403656 |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2004-06-22 |