FDA Adverse Event
Injury
Summary report: N
VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING
MDR report key: 515379
·
Received March 11, 2004
Report
- Report Number
- 6000043-2004-00016
- Event Type
- Injury
- Date Received
- March 11, 2004
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- FHK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT SUBSEQUENT TO THE IMPLANT OF A PROTEGEN SLING FOR TREATMENT IN 1998, THE PT "WAS HAVING AN EXAM AND THE SLING CAME OUT ON ITS OWN" IN MARCH OF 2003. THE PT EXPERIENCED LEAKING AND HAD A STERILE ABSCESS FROM THE SLING. SUBSEQUENT TO THE REMOVAL, THE PT WAS TOTALLY INCONTINENT. THE PT HAD A SUBSEQUENT PROCEDURE IN THE FALL OF 2003.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING | PERC STABILIZATION KIT | FHK | BOSTON SCIENTIFIC CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |