MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,04,05,06,07 report with the FDA on 2002-12-27 for PROTEGEN SLING AND VESICA KIT W/PROTEGEN SLING * manufactured by Microvasive Urology A Division Of Boston Scientific Corp..
[285088]
This mdr form summarizes complaints associated with the "traditional" (bsc complaint files, post marketing studies, litigation activities and engineering field reports) complaints for the protegen and vesica sling kit in which a serious injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000043-2002-00182 |
| MDR Report Key | 434852 |
| Report Source | 02,04,05,06,07 |
| Date Received | 2002-12-27 |
| Date Reported to FDA | 2002-11-06 |
| Date Added to Maude | 2002-12-31 |
| 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 | 0 |
| 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 | PROTEGEN SLING AND VESICA KIT W/PROTEGEN SLING |
| Generic Name | PERC STABLIZATION KIT |
| Product Code | FHK |
| Date Received | 2002-12-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 423805 |
| 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 | 2002-12-27 |