FDA Adverse Event
Malfunction
Summary report: N
LRG KOOL GRIP MALLET W/PL.HD.
MDR report key: 2051485
·
Received April 4, 2011
Report
- Report Number
- 9610726-2011-00097
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 17, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME EVENT AS MFR.# 9610726-2011-00098, 9610726-2011-00098.
Description of Event or Problem · 1
THE CUSTOMER CLAIMS TO HAVE PROBLEMS WITH THE HEADS OF THE HAMMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LRG KOOL GRIP MALLET W/PL.HD. | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS LIMERICK | NA | MJE26W1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |