FDA Adverse Event
Malfunction
Summary report: N
JARIT 350-370
MDR report key: 5996424
·
Received September 30, 2016
Report
- Report Number
- MW5065158
- Event Type
- Malfunction
- Date Received
- September 30, 2016
- Date of Event
- September 29, 2016
- Report Date
- September 30, 2016
- Manufacturer
- JARIT
- Product Code
- KCH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
WHEN USING A 2 PRONG SKIN HOOK A PIECE CAME OFF THE METAL SKIN HOOK WHICH WAS THEN SECURED AND NOT LEFT IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643833 | JARIT 350-370 | SKIN HOOK | KCH | JARIT | 100088-1401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |