MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-03-10 for 820-121 manufactured by Microvasive Urology.
[20996900]
It was reported that subsequent to the implant of a protegen sling for treatment of urinary incontinence, symptoms returned and the device was explanted. The device was not returned for eval. Therefore, no failure analysis is available. Without evaluating this device, co was unable to determine if the device met specs, and co was unable to determine the specific relationship of the device to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000043-2003-00022 |
| MDR Report Key | 448439 |
| Report Source | 05,06 |
| Date Received | 2003-03-10 |
| Date of Report | 2003-02-11 |
| Date of Event | 2000-11-14 |
| Date Reported to FDA | 2003-03-10 |
| Date Mfgr Received | 2003-02-11 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 2003-03-19 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NANCY MICHAUD |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760153 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760153 |
| Manufacturer Phone | 5086508349 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PUBOVAGINAL SLING |
| Product Code | FHK |
| Date Received | 2003-03-10 |
| Model Number | NA |
| Catalog Number | 820-121 |
| Lot Number | 167127 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 437417 |
| Manufacturer | MICROVASIVE UROLOGY |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 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. Required No Informationntervention | 2003-03-10 |