FDA Adverse Event
Malfunction
Summary report: N
KX+FEM IMPACTOR
MDR report key: 105187
·
Received July 7, 1997
Report
- Report Number
- 2219689-1997-00355
- Event Type
- Malfunction
- Date Received
- July 7, 1997
- Report Date
- July 2, 1997
- Manufacturer
- HOWMEDICA INC.
- Product Code
- HWA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUMMARY OF EVALUATION: HANDLE CRACKING IS TYPICALLY CAUSED BY REPETITIVE EXPOSURE TO ACIDIC CHEMICALS IN THE HOSPITAL CONTAMINATION PROCESS, AND POSSIBLE, ACCELARATION BY MECHANICAL AND THERMA EFFECTS.
Description of Event or Problem · 1
THE BLACK HANDLE ON BOTH INSTRUMENTS IS CRACKED. THIS WAS NOTICED DURING A ROUTINE INSTRUMENT INSPECTION AT THE AGENCY OFFICE. THEREFORE, THERE WAS NO PT INVOLVEMENT AND THUS, NO ADVERSE CONSEQUENCE FOR ANY PT.
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 |