MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-05-15 for SPARC SLING SYSTEM manufactured by American Medical Systems, Inc..
[17409976]
It was reported the pt was implanted with a sparc sling system and another manufacturer's mesh on or about (b)(6) 2002 to revise/repair a previous mesh device (another manufacturer's mesh device) that was implanted on or about (b)(6) 2000. The pt experienced mental and physical pain and suffering, dyspareunia, vaginal and mesh erosion, hardening, dense scarring, recurrent incontinence, and permanent injury. The pt underwent non-specified surgery.
Patient Sequence No: 1, Text Type: D, B5
[17646829]
Should additional info become available regarding this event it will be re-evaluated and a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2012-00630 |
| MDR Report Key | 2581243 |
| Report Source | 04 |
| Date Received | 2012-05-15 |
| Date of Report | 2012-04-24 |
| Date Mfgr Received | 2012-04-24 |
| Date Added to Maude | 2012-05-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RANDY HOYT, SR. MANAGER |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306277 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPARC SLING SYSTEM |
| Generic Name | SURGICAL MESH |
| Product Code | FHK |
| Date Received | 2012-05-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2012-05-15 |