FDA Adverse Event
Malfunction
Summary report: N
KX+ FEM IMPACTOR
MDR report key: 191908
·
Received October 12, 1998
Report
- Report Number
- 2219689-1998-00579
- Event Type
- Malfunction
- Date Received
- October 12, 1998
- Report Date
- October 12, 1998
- Manufacturer
- HOWMEDICA INC.
- Product Code
- HWA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE HANDLE OF THE IMPACTOR CRACKED ALLEGEDLY DUE TO EXCESSIVE USE. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KX+ FEM IMPACTOR | INSTRUMENT | HWA | HOWMEDICA INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |