FDA Adverse Event
Malfunction
Summary report: N
CERAMOPIC
MDR report key: 158102
·
Received March 19, 1998
Report
- Report Number
- MW1013295
- Event Type
- Malfunction
- Date Received
- March 19, 1998
- Date of Event
- February 18, 1998
- Report Date
- February 19, 1998
- Manufacturer
- CERAMOPTEC, INC.
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CERAMOPIC | LASER FIBER | GEX | CERAMOPTEC, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |