OtherILO
UNKNOWN
Received Mar 24, 2011 · Event occurred Jun 5, 2009
Report 2028253-2011-00011 · MDR key 2040194
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Injury
Narrative
Description of Event or Problem
BREG RECEIVED LEGAL NOTICE OF LAWSUITS FOR 'UNK COLD THERAPY UNIT' 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. FIRST NOTIFICATION WAS SERVICE OF LAWSUIT ON (B)(6) 2011.