FDA Adverse Event
Malfunction
Summary report: N
6000032-1998-00023
MDR report key: 148662
·
Received February 9, 1998
Report
- Report Number
- 6000032-1998-00023
- Event Type
- Malfunction
- Date Received
- February 9, 1998
- Date of Event
- January 8, 1997
- Product Code
- GZB
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
AFTER SEVERAL ATTEMPTS, MFR WAS UNABLE TO OBTAIN MORE INFO ABOUT THE REPORTED EVENT FROM THE USER FACILITY, AND IS THEREFORE UNABLE TO VERIFY WHETHER THERE WAS ANY TYPE OF INJURY AS A RESULT OF THE ALLEGED DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GZB | 3487A | L41700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |