MalfunctionFEN
TDOC-7FS AIR-CHARGED SINGLE SENSOR CATHETER
Received Feb 24, 2023 · Event occurred Dec 29, 2022
Report 16434945 · MDR key 16434945
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Laborie Medical Technologies Canada UlcModel number
CAT895Lot number
221808
Product problems
- Inflation Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE BALLOON FAILED TO INFLATE DURING THE PROCEDURE.