FDA Adverse Event
Other
Summary report: N
POLAR CARE KODIAK
MDR report key: 2040195
·
Received March 24, 2011
Report
- Report Number
- 2028253-2011-00009
- Event Type
- Other
- Date Received
- March 24, 2011
- Report Date
- March 14, 2011
- Manufacturer
- BREG, INC
- Product Code
- ILO
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BREG RECEIVED LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 7 IN TOTAL, 1 FOR POLAR CARE KODIAK, ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND REPORTER HAS NO KNOWLEDGE IF THIS TERM MEETS THE REQUIREMENTS OF SERIOUS INJURY AS DEFINED BY CURRENT FDA GUIDELINES. BREG HAS REVIEWED INTERNAL COMPLAINT FILES AND MAUDE DATABASE AND FINDS NO RECORD OF PREVIOUS NOTICE OF THESE "PERSONAL INJURY" CLAIMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLAR CARE KODIAK | 89ILO | ILO | BREG, INC | KODIAK | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |