MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-08-03 for SPARC SLING SYSTEMS 72403830 NA manufactured by American Medical Systems, Inc..
[360812]
A pt was at the doctor's office for a follow-up visit after a monarc sling system procedure. The doctor determined the sling was extruding through the vaginal wall. The doctor believes that a suture gave way and the sling then protruded through the vaginal incision and the pt healed with part of the sling outside the vaginal wall. The doctor removed the portion of the sling that was protruding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2004-00031 |
| MDR Report Key | 537847 |
| Report Source | 05 |
| Date Received | 2004-08-03 |
| Date of Report | 2004-07-30 |
| Date of Event | 2004-07-01 |
| Date Mfgr Received | 2004-07-01 |
| Date Added to Maude | 2004-08-09 |
| 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 | 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 | 6129306624 |
| 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 | 2004-08-03 |
| Model Number | 72403830 |
| 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 | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 527095 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US |
| Baseline Brand Name | MONARC SLING SYSTEMS |
| Baseline Generic Name | SPARC/OTHER SLING TYPES |
| Baseline Model No | 72403830 |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2004-08-03 |