FDA Adverse Event
Malfunction
Summary report: N
TDOC-7FS AIR-CHARGED SINGLE SENSOR CATHETER
MDR report key: 16434945
·
Received February 24, 2023
Report
- Report Number
- 16434945
- Event Type
- Malfunction
- Date Received
- February 24, 2023
- Date of Event
- December 29, 2022
- Report Date
- February 14, 2023
- Manufacturer
- LABORIE MEDICAL TECHNOLOGIES CANADA ULC
- Product Code
- FEN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE BALLOON FAILED TO INFLATE DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1871081 | TDOC-7FS AIR-CHARGED SINGLE SENSOR CATHETER | DEVICE, CYSTOMETRIC, HYDRAULIC | FEN | LABORIE MEDICAL TECHNOLOGIES CANADA ULC | CAT895 | 221808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |