FDA Adverse Event
Other
Summary report: N
LONG NAIL KIT R1.5, TI, LEFT 10X260MM X 130
MDR report key: 1594685
·
Received February 2, 2010
Report
- Report Number
- 9610622-2010-00048
- Event Type
- Other
- Date Received
- February 2, 2010
- Date of Event
- January 15, 2010
- Report Date
- January 15, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K034002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
WHEN THE NURSE OPENED THE PACKAGE, SHE FOUND THE HAIR ON THE TOP OF THE BLISTER PACKAGE. THE SURGEON DECIDED TO USE THAT NAIL. SO THE PROCEDURE WAS COMPLETED WITH NO PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LONG NAIL KIT R1.5, TI, LEFT 10X260MM X 130 | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K231099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |