FDA Adverse Event
Malfunction
Summary report: N
THERMODILUTION CATHETER
MDR report key: 23971
·
Received November 9, 1994
Report
- Report Number
- 2247092-1994-00001
- Event Type
- Malfunction
- Date Received
- November 9, 1994
- Report Date
- October 26, 1994
- Manufacturer
- NOVA MEDICAL SPECIALTIES
- Product Code
- KRB
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
"BALLOON BURST ONE (1) OR TWO (2) DAYS AFTER INSERTION" AS REPORTED FROM INITIAL REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMODILUTION CATHETER | BALLOON THERMODILUTION CATHETER | KRB | NOVA MEDICAL SPECIALTIES | K55/1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |