MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,06,07 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..
[15380470]
This mdr form summarizes complaints associated with the "non-traditional" (bsc sales territory manager surveys) 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 | 6000043-2002-00183 |
| MDR Report Key | 434868 |
| Report Source | 02,05,06,07 |
| 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 STABLIZAITON 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 | 423820 |
| 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 |