FDA Adverse Event
Injury
Summary report: N
PAIN CARE 4200
MDR report key: 1833125
·
Received September 9, 2010
Report
- Report Number
- 2028253-2010-00021
- Event Type
- Injury
- Date Received
- September 9, 2010
- Date of Event
- February 9, 2004
- Report Date
- August 26, 2010
- Manufacturer
- BREG, INC
- Product Code
- MEB
- PMA / PMN Number
- K020988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT HAD SURGERY ON (B)(6) 2004 TO RESPECT A DISPLACING TEAR OF ANTERIOR INFERIOR RIGHT GLENOID LABRUM AND ARTHROSCOPIC ANTERIOR DECOMPRESSION. DOCTOR PLACED A PAIN CARE 4200 CATHETER. PT ALLEGES GLENOHUMERAL CHONDROLYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PAIN CARE 4200 | 89MRB | MEB | BREG, INC | 4200 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Disability |