FDA Adverse Event
Injury
Summary report: N
R-I-FLOW PAIN BUSTER
MDR report key: 1071563
·
Received July 9, 2008
Report
- Report Number
- MW5007565
- Event Type
- Injury
- Date Received
- July 9, 2008
- Date of Event
- June 21, 2001
- Report Date
- July 2, 2008
- Manufacturer
- R-I-FLOW CORPORATION
- Product Code
- MEB
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN 2001 - ROTATOR CUFF REPAIR W/ ACROMIOPLASTY; REPAIR OF SLAP LESION; EXCISION DISTAL CLAVICLE & PAIN BUSTER PAIN PUMP PLACEMENT IN RIGHT SHOULDER JOINT AND IN SUBACROMIAL SPACE. IN 2002 - ARTHROSCOPIC LEFT SLAP REPAIR, LEFT SHOULDER WITH PAIN PALM ANESTHETIC PUMP PLACED IN LEFT GLENOHUMERAL SPACE. ON ORIGINAL DATE, PAIN BUSTER IN RIGHT SHOULDER JOINT. IN 2002 - ZIMMER- LEFT GLENOHUMERAL SPACE, PALM PUMP IS A TRADEMARK OF SORENSON MEDICAL, INC. DOSE OR AMOUNT: 270 CC, FREQUENCY: UNK, ROUTE: 014. DOSE OR AMOUNT 300 CC, FREQUENCY: UNK, ROUTE: 014. DATES OF USE: 2001 TO UNKNOWN, DATES OF USE: 2002 TO UNKNOWN. DIAGNOSIS OR REASON FOR USE: ROTATOR CUFF TEAR & SLAP -RT. DIAGNOSIS OR REASON FOR USE: SLAP LESION, LEFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | R-I-FLOW PAIN BUSTER | R-PAIN BUSTER | MEB | R-I-FLOW CORPORATION | UNK | UNK | |
| 2 | L- PUMP PALM ANESTHETIC | L-PUMP PALM ANESTHETIC | MEB | L- ZIMMER, SUBSIDIARY OF BRISTOL-MYERS SQUIBB COMPANY | UNK | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | 2% LIDOCAINE W/ EPINEPHRINE| 270 CC 0.5% MARCAINE W/ EPINEPHRINE |