MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-03-11 for VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING UNK manufactured by Boston Scientific Corp..
[15448529]
It was reported that subsequent to the implant of a protegen sling for treatment in 1998, the pt began experiencing pain, discharge, odor, and ulcers in november of 2003. After condition worsened, the sling was removed in 2004.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000043-2004-00014 |
| MDR Report Key | 515388 |
| Report Source | 05,06 |
| Date Received | 2004-03-11 |
| Date of Report | 2004-01-28 |
| Date of Event | 2003-11-30 |
| Date Added to Maude | 2004-03-15 |
| 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 | 0 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 017601537 |
| Manufacturer Country | US |
| Manufacturer Postal | 017601537 |
| Manufacturer Phone | 5086525066 |
| Manufacturer G1 | BOSTON SCIENTIFIC |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| 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 | 2004-03-11 |
| 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 | V |
| Device Sequence No | 1 |
| Device Event Key | 504396 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 780 BROOKSIDE DR. SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-03-11 |