FDA Adverse Event
Injury
Summary report: N
PAIN CARE
MDR report key: 1833124
·
Received September 9, 2010
Report
- Report Number
- 2028253-2010-00022
- Event Type
- Injury
- Date Received
- September 9, 2010
- Date of Event
- August 31, 2004
- Report Date
- August 26, 2010
- Manufacturer
- BREG, INC
- Product Code
- MEB
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT HAD SURGERY OF RIGHT SHOULDER SUBACROMIAL DECOMPRESSION AND DEBRIDEMENT AND WAS GIVEN A DIAGNOSIS OF ROTATOR CUFF SYNDROME AND ADHESIVE CAPSULITIS. DOCTOR INSERTED A CATHETER AND PAIN PUMP FOR POST OPERATIVE PAIN. THE MFR OF THE PAIN PUMP WAS NOT NOTED IN THE MEDICAL RECORDS. SUBSEQUENTLY IN 2009, THE OPERATIONS MGR AT THE PRACTICE WROTE A LETTER STATING THAT THEY USED BERG PUMPS UP UNTIL (B)(6) 2005. PT ALLEGES GLENOHUMERAL CHONDROLYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PAIN CARE | 89MRB | MEB | BREG, INC | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Disability |