FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE PET BALLOON DILATORS
MDR report key: 1010110
·
Received March 10, 2008
Report
- Report Number
- 9710641-2008-00029
- Event Type
- Malfunction
- Date Received
- March 10, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 8, 2008
- Manufacturer
- JUAREZ FACILITY
- Product Code
- KNQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. UNABLE TO DETERMINED CAUSE OF EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "IN 2008, THE FACILITY WAS USING CAT. #000345, LOT #0708201. THEY TRIED TO INFLATE THE BALLOON, IT DID NOT REGISTER ON THE MANOMETER, THE MANOMETER WAS SWITCHED AND STILL NO READING OF THE INFLATION. THE DOCTOR PUSHED THE BALLOON INTO THE PATIENT'S STOMACH TO CHECK FOR INFLATION AND THEY FOUND THAT THE BALLOON WAS FULLY INFLATED. THE BALLOON WOULD NOT DEFLATE AND HAD TO BE CUT WITH A WIRE CUTTER TO DEFLATE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE PET BALLOON DILATORS | ESOPHAGEAL BALLOON DILATOR | KNQ | JUAREZ FACILITY | 0708201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |