FDA Adverse Event
Malfunction
Summary report: N
DONJOY PAIN BUSTER
MDR report key: 997179
·
Received February 8, 2008
Report
- Report Number
- MW5005371
- Event Type
- Malfunction
- Date Received
- February 8, 2008
- Date of Event
- January 25, 2008
- Report Date
- February 8, 2008
- Manufacturer
- DONJOY DJO, LLC
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DON JOY PAIN MANAGEMENT PUMP FAILED TO DELIVER ANESTHETIC. DEVICE HOLDS 120CC TO BE DELIVERED OVER 48 HOURS. PRODUCT REF-11-1453 LOT #60883811. EXP. DATE: 08/2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DONJOY PAIN BUSTER | NONE | MEB | DONJOY DJO, LLC | 11-1453 | 60883811 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |