FDA Adverse Event
Malfunction
Summary report: N
8022103-1997-00001
MDR report key: 141165
·
Received December 30, 1997
Report
- Report Number
- 8022103-1997-00001
- Event Type
- Malfunction
- Date Received
- December 30, 1997
- Date of Event
- October 30, 1997
- Product Code
- KCT
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
WIDE VARIATION IN STEAM INDICATOR INK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |