InjuryFHK
VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING
Received Mar 11, 2004
Report 6000043-2004-00016 · MDR key 515379
Device
Generic name
Perc Stabilization Kit
Manufacturer
Boston Scientific Corp.Model number
NACatalog number
UNK
Lot number
UNK
Product problems
- Explanted
- Leak/Splash
Patient
NA
- Syncope
- Abscess
- Incontinence
- Surgical procedure
Narrative
Description of Event or Problem
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.