FDA Adverse Event
Injury
Summary report: N
PAIN CARE 3200
MDR report key: 1600637
·
Received February 10, 2010
Report
- Report Number
- 2028253-2010-00004
- Event Type
- Injury
- Date Received
- February 10, 2010
- Date of Event
- January 5, 2007
- Report Date
- February 8, 2010
- Manufacturer
- BREG, INC.
- Product Code
- MEB
- PMA / PMN Number
- K013928
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PT HAD SHOULDER SURGERY ON (B) (6) 2007. A PAIN CARE 3200 WAS USED DURING THE SURGERY. PT NOW ALLEGES THAT HE HAS GLENOHUMERAL CHONDROLYSIS IN THE SHOULDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PAIN CARE 3200 | INFUSION PUMP | MEB | BREG, INC. | PAIN CARE 3200 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Disability |