FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL BLOCK TRAY
MDR report key: 3231865
·
Received July 15, 2013
Report
- Report Number
- 1722447-2013-00012
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Report Date
- July 15, 2013
- Manufacturer
- INTEGRA PAIN MANAGEMENT
- Product Code
- FMF
- PMA / PMN Number
- K960248
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
PACKAGING WAS RIPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325456 | UNIVERSAL BLOCK TRAY | 44 - TRAYS | FMF | INTEGRA PAIN MANAGEMENT | W1301054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |