MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-01-21 for VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING UNK manufactured by Microvasive Urology.
[349722]
It was reported that subsequent to the implant of a protegen sling for treatment in 97, the pt experienced vaginal bleeding, foul odor, vaginal erosion, pain, discharge, sexual complications, continued incontinence, suffering and mental anguish.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000043-2004-00001 |
| MDR Report Key | 507368 |
| Report Source | 04 |
| Date Received | 2004-01-21 |
| Date of Report | 2003-01-07 |
| Date Reported to FDA | 2004-01-21 |
| Date Mfgr Received | 2003-11-07 |
| Date Added to Maude | 2004-01-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760153 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760153 |
| Manufacturer Phone | 5086525066 |
| Manufacturer G1 | MICROVASIVE UROLOGY |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING |
| Generic Name | PERC STABILIZATION KIT |
| Product Code | FHK |
| Date Received | 2004-01-21 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 496303 |
| Manufacturer | MICROVASIVE UROLOGY |
| Manufacturer Address | 780 BROOKSIDE DR. SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-01-21 |