MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2002-10-02 for VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING UNK manufactured by Microvasive Urology/a Division Of Boston Scientific Corp..
[19778610]
The pt reported that subsequent to the implant of a protegen sling for treatment, they experienced pelvic pain, vaginal bleeding, increased urinary tract infections, yeast infections and odor. The pt reported the sling became infected and had to be removed. Pt reported that one of the bone screws dislodged and was free floating and the other bone screw couldn't be located. Since removal of the sling, pt has increased urinary frequency for which the pt takes imipramine and they use twelve pads a day for incontinence. Pt continues to have lower back pain, groin pain, pain and numbness in their right leg. The pt reports that due to injuries caused by the sling, they are homebound. The device was not returned for evaluation. Therefore, no failure analysis is available. Without evaluating this device, co is unable to determine if the device met specifications, 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 | 6000043-2002-00174 |
| MDR Report Key | 420470 |
| Report Source | 04 |
| Date Received | 2002-10-02 |
| Date of Report | 2002-09-05 |
| Date Reported to FDA | 2002-10-02 |
| Date Mfgr Received | 2002-09-05 |
| Date Added to Maude | 2002-10-08 |
| 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 | 2002-10-02 |
| 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 | 409526 |
| Manufacturer | MICROVASIVE UROLOGY/A DIVISION OF BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-10-02 |