MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-10 for PROTEGEN SLING * 820-121 manufactured by Boston Scientific.
[20770897]
Protegen transvaginal sling placed in 1998 for urinary incontinence. Symptoms returned. Product removed in 2000.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 448434 |
| MDR Report Key | 448434 |
| Date Received | 2003-03-10 |
| Date of Report | 2003-01-24 |
| Date of Event | 2000-11-14 |
| Date Added to Maude | 2003-03-19 |
| 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 | PROTEGEN SLING |
| Generic Name | TRANSVAGINAL SLING GRAFT |
| Product Code | FHK |
| Date Received | 2003-03-10 |
| Model Number | * |
| Catalog Number | 820-121 |
| Lot Number | 167127 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 437417 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | P.O. BOX 951653 DALLAS TX 75395 US |
| Baseline Brand Name | VESICA PERC STABILIZATION KIT W/ PROTEGEN SLING |
| Baseline Generic Name | PERC STABILIZATION KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 820-121 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-03-10 |