MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-01-15 for VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING UNK manufactured by Microvasive Urology.
[284559]
The pt reported that subsequent to the implant of a protegen sling for treatment in 1997, pt experienced pain, problems with urination including difficulty with urination and incontinence, infection, and erosion of foreign matter into their bladder. The pt reported in 1998, a cystostomy and urethral dilation were performed. In 5/1999, an ultrasound was performed. In 1999 repeat cystoscopies with urethral dilation were performed. In 2001, the pt reported surgery was performed and it was discovered that a stitch and/or other foreign object had been left in during the first surgery. 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 is unable to determine the specific relationship of the device to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000043-2003-00002 |
| MDR Report Key | 438211 |
| Report Source | 04 |
| Date Received | 2003-01-15 |
| Date of Report | 2002-12-17 |
| Date Reported to FDA | 2003-01-15 |
| Date Mfgr Received | 2002-12-17 |
| Date Added to Maude | 2003-01-22 |
| 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 |
| 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 |
| Brand Name | VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING |
| Generic Name | PERC STABILIZATION KIT |
| Product Code | FHK |
| Date Received | 2003-01-15 |
| 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 | U |
| Device Sequence No | 1 |
| Device Event Key | 427127 |
| Manufacturer | MICROVASIVE UROLOGY |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-01-15 |