FDA Adverse Event
Malfunction
Summary report: N
KX+ FEM IMPACTOR
MDR report key: 190179
·
Received October 1, 1998
Report
- Report Number
- 2219689-1998-00573
- Event Type
- Malfunction
- Date Received
- October 1, 1998
- Report Date
- September 30, 1998
- Manufacturer
- HOWMEDICA INC
- Product Code
- HWA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HANDLE OF IMPACTOR HAS CRACKED. THIS EVENT DID NOT OCCUR DURING A SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KX+ FEM IMPACTOR | INSTRUMENT | HWA | HOWMEDICA INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |