MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-24 for SHELHIGH SHP-555-315 * manufactured by Shelhigh.
[176605]
In 1999 pt underwent transvaginal fascial sling and cystocele repair using a bovine percardial patch. Post-op, the pt was treated for intermittent urinary tract infections but no erosion of the sling. However in 01/2000 pt had bleeding and upon exam the previously healing incision was open with the graft exposed and evidence of infection was present. In 2000 pt had graft removed and underwent bladder neck reconstruction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 266572 |
| MDR Report Key | 266572 |
| Date Received | 2000-02-24 |
| Date of Report | 2000-02-24 |
| Date of Event | 2000-01-28 |
| Date Facility Aware | 2000-02-14 |
| Report Date | 2000-02-24 |
| Date Reported to FDA | 2000-02-24 |
| Date Added to Maude | 2000-03-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHELHIGH |
| Generic Name | BOVINE PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 2000-02-24 |
| Model Number | SHP-555-315 |
| Catalog Number | * |
| Lot Number | 980904-SHP |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 5 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 258065 |
| Manufacturer | SHELHIGH |
| Manufacturer Address | * MILBURN NJ 07041 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-02-24 |