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.
[20244100]
In 1999, pt underwent transvaginal fascial sling for stress incontinence with use of bovine pericardial patch. Postop pt had no incontinence and was healing well except for a small area that did not close completely but no graft exposed. In 2000, pt began having vaginal discharge, despite treatment with antibiotics this did not improve. In 2000, pt had graft removed and underwent repair of surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 266582 |
| MDR Report Key | 266582 |
| Date Received | 2000-02-24 |
| Date of Report | 2000-02-24 |
| Date of Event | 2000-01-12 |
| 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 | 258075 |
| Manufacturer | SHELHIGH |
| Manufacturer Address | * MILBURN NJ 07041 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-02-24 |