FDA Adverse Event
Other
Summary report: N
MILTEX
MDR report key: 108049
·
Received July 25, 1997
Report
- Report Number
- 2431021-1997-00005
- Event Type
- Other
- Date Received
- July 25, 1997
- Date of Event
- July 17, 1997
- Report Date
- July 22, 1997
- Manufacturer
- MILTEX INSTRUMENT CO., INC.
- Product Code
- HNF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CURVED TIP OF IRIS SCISSOR BROKE AND FELL OFF INTO BIOPSEY, INCISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILTEX | IRIS SCISSOR, CURVED | HNF | MILTEX INSTRUMENT CO., INC. | 5-SC-306TC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention |