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.
[16359788]
In 1999, pt underwent transvaginal fascial sling and cystocele repair using pericardial patch. Despite mild residual urine incision was healed and pt released to normal activity including marital relations. In 01/2000, pt had bleeding and vaginal discharge. Exam showed graft to be exposed with evidence of infection. In 2000, pt had graft removed and repair of surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 266576 |
| MDR Report Key | 266576 |
| Date Received | 2000-02-24 |
| Date of Report | 2000-02-24 |
| Date of Event | 2000-01-21 |
| 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 | 980826-SHP |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 4 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 258069 |
| Manufacturer | SHELHIGH |
| Manufacturer Address | * MILBURN NJ 07041 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-02-24 |