UNKNOWN
Received Mar 24, 2011
Report 2028253-2011-00010 · MDR key 2040192
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Injury
Narrative
Description of Event or Problem
BREG RECEIVED LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 7 IN TOTAL, 2 FOR 'UNK COLD THERAPY' 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.
Description of Event or Problem
BREG RECEIVED LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 7 IN TOTAL, 2 FOR 'UNK COLD THERAPY' 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.