FDA Adverse Event
Malfunction
Summary report: N
KMEDIC SCREW DRIVER HEX 2.5MM W/O SLEEVE
MDR report key: 3020997
·
Received March 20, 2013
Report
- Report Number
- 3005236665-2013-00001
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 28, 2013
- Report Date
- March 5, 2013
- Manufacturer
- KMEDIC EUROPE GMBH, TELEFLEX MEDICAL
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SAMPLE WAS NOT RETURNED IN TIME FOR THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: ALLEGED ISSUE - THE TIP FELL OFF DURING SURGERY ON A DOG. IT WAS RETRIEVED AND NO INJURY WAS REPORTED TO DOG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116844 | KMEDIC SCREW DRIVER HEX 2.5MM W/O SLEEVE | SCREW DRIVER | HXX | KMEDIC EUROPE GMBH, TELEFLEX MEDICAL | QQ8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |