OtherEXX
UNIFIX ANORECTAL BALLOON HOLDER
Received Nov 14, 2013 · Event occurred Oct 15, 2013
Report 2023374-2013-00001 · MDR key 3535776
Device
Generic name
Unifix Anorectal Balloon Holder
Manufacturer
Sandhill Scientific, Inc.Model number
A86-4400-10Catalog number
A86-4400-10
Lot number
NA
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
THE BAND HOLDER DID NOT HOLD THE BALLOON ON THE ANORECTAL PROBE WHEN THE PROBE WAS REMOVED. THE BALLOON WAS LOST WITHIN THE PATIENT'S COLON. A SIGMOIDOSCOPY WAS PERFORMED TO REMOVE THE BALLOON.
Remedial action
- Other