FDA Adverse Event
Malfunction
Summary report: N
TPE BALLOON
MDR report key: 4645893
·
Received February 13, 2015
Report
- Report Number
- 9611668-2014-00001
- Event Type
- Malfunction
- Date Received
- February 13, 2015
- Date of Event
- July 25, 2014
- Report Date
- February 13, 2015
- Manufacturer
- MUI SCIENTIFIC
- Product Code
- FFX
- PMA / PMN Number
- K823701
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL LOT # 092713. ADDITIONAL DEVICE MANUFACTURE DATE: 09/27/2013.
Description of Event or Problem · 1
A SOLID-STATE CATHETER WITH A BALLOON ATTACHED WAS INSERTED INTO THE PATIENTS RECTUM FOR A MOTILITY STUDY. UPON REMOVAL OF THE CATHETER, THE BALLOON REMAINED WITHIN THE PATIENT'S BODY, THE PATIENT WAS ASKED TO EXPEL THE BALLOON DURING THE NEXT BOWEL MOVEMENT, TO NO SUCCESS. THE PATIENT WAS ASKED TO MONITOR HER BOWEL MOVEMENTS FOR SIGNS OF THE BALLOON OVER THE WEEKEND, STILL TO NO SUCCESS. THE PATIENT WAS ASKED TO RETURN TO THE HOSPITAL, WHERE THE BALLOON WAS SUCCESSFULLY REMOVED USING A FLEXIBLE SIGMOIDOSCOPE WITHOUT ANY COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 108972 | TPE BALLOON | ANORECTAL MOTILITY BALLOON | FFX | MUI SCIENTIFIC | 092413 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |