FDA Adverse Event
Injury
Summary report: N
PAIN CARE 2000
MDR report key: 1612546
·
Received February 9, 2010
Report
- Report Number
- 2028253-2010-00003
- Event Type
- Injury
- Date Received
- February 9, 2010
- Date of Event
- December 28, 1999
- Report Date
- February 5, 2010
- Manufacturer
- BREG INC.
- Product Code
- MEB
- PMA / PMN Number
- K983454
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PT HAD LEFT SHOULDER SURGERY ON (B) (6) 1999 TO REPAIR A RECURRENT DISLOCATION OF THE LEFT SHOULDER. A PAIN CARE 2000 WAS USED DURING THE SURGERY. PT NOW ALLEGES THAT HE HAS GLENHUMERAL CHONDROLYSIS IN THIS SHOULDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PAIN CARE 2000 | INFUSION PUMP | MEB | BREG INC. | PAIN CARE 2000 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Disability |