MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-11-12 for SPARC SLING SYSTEMS manufactured by American Medical Systems, Inc..
[376551]
A sparc sling was eroded into the vagina. In 04/2004 the doctor pushed the sling up and flattened it due to its twisted state. The sling had twisted and the edge of the sling was pushing into the vaginal wall. The doctor placed sutures to keep it flattened. Due to severe pain in the groin and vagina area the doctor loosened some of the stitches a week later. Due to pain the doctor removed the sling in about 4 months. The pt continued to complain of pain after the sling removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2004-00047 |
| MDR Report Key | 555760 |
| Report Source | 00 |
| Date Received | 2004-11-12 |
| Date of Report | 2004-11-11 |
| Date of Event | 2004-08-27 |
| Date Mfgr Received | 2004-11-05 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2004-11-22 |
| 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 | RANDY HOYT,MDR, CONTACT |
| Manufacturer Street | 10700 BREN ROAD WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306277 |
| 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 | 2004-11-12 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 363861004 |
| ID Number | * |
| Device Expiration Date | 2004-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 545411 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2004-11-12 |