FDA Adverse Event
Other
Summary report: N
SIMPLEX P FULL DOSE 1 PACK
MDR report key: 1310852
·
Received February 10, 2009
Report
- Report Number
- 9610726-2009-00016
- Event Type
- Other
- Date Received
- February 10, 2009
- Date of Event
- January 15, 2009
- Report Date
- January 15, 2009
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- N17004
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "AFTER COMPONENT WAS IMPLANTED RESIDENT CLEANING OFF EXCESS AROUND THE IMPLANT, THE EXCESS PLACED IN HIS HAND AND CEMENT CAUGHT ON FIRE IN HIS HAND. DROPPED TO GROUND AND STOMPED OUT. BOVIE NOT IN USE, NOTHING UNUSUAL, SETTING NORMAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P FULL DOSE 1 PACK | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | RKP215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |