InjuryFHK
VESICA PERCUTANEOUS BLADDER NECK SUSPENSION KIT
Received Oct 17, 2005 · Event occurred Oct 11, 2005
Report 6000043-2005-00090 · MDR key 641498
Device
Generic name
Bladder Neck Suspension
Manufacturer
Boston Scientific Corp.Model number
*Catalog number
000-820
Lot number
*
Product problems
- Explanted
Patient
NA
- Unspecified Infection
- Surgical procedure
Narrative
Description of Event or Problem
THE COMPLAINANT HAS REPORTED THAT A FEMALE PT UNDERWENT A THERAPEUTIC VESICA PERCUTANEOUS BLADDER NECK SUSPENSION SLING PLACEMENT APPROXIMATELY 8 YEARS AGO. THE PT EXPERIENCED AN INFECTION. SPECIFIC DETAILS ON NATURE AND DURATION OF INFECTION TIME LINE ARE NOT AVAILABLE. IN 2005 THE PT HAD THE SLING REMOVED VIA A MID-LINE INCISION. THE PROCEDURE WAS NOTED TO BE SUCCESSFUL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.