MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-09-27 for SPARC SLING SYSTEM 72403480 NA manufactured by American Medical Systems, Inc..
[261116]
Patient had sparc sling implanted in 2002. Patient later complained to physician of nausea, abdominal pain, distended abdomen. Patient had 2nd surgery 5 days later which revealed a small bowel perforation. Doctor repaired perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2002-00070 |
| MDR Report Key | 419411 |
| Report Source | 05 |
| Date Received | 2002-09-27 |
| Date of Report | 2002-09-27 |
| Date of Event | 2002-07-24 |
| Date Mfgr Received | 2002-08-12 |
| Date Added to Maude | 2002-10-03 |
| 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 |
| 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 SYSTEM |
| Generic Name | SPARC SLING SYSTEM |
| Product Code | FHK |
| Date Received | 2002-09-27 |
| Model Number | 72403480 |
| Catalog Number | NA |
| Lot Number | 348560019 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 408458 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US |
| Baseline Brand Name | SPARC SLING SYSTEM |
| Baseline Generic Name | SPARC SLING SYSTEM |
| Baseline Model No | 72403480 |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-09-27 |