UNKNOWN
Received Feb 9, 2011
Report 2028253-2011-00004 · MDR key 1999195
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Injury
Narrative
Description of Event or Problem
BREG REC'D LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 24 IN TOTAL, 5 FOR 'UNK COLD THERAPY' ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND RPTR 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.
Description of Event or Problem
BREG REC'D LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 24 IN TOTAL, 5 FOR 'UNK COLD THERAPY' ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND RPTR 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.
Description of Event or Problem
BREG REC'D LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 24 IN TOTAL, 5 FOR 'UNK COLD THERAPY' ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND RPTR 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.
Description of Event or Problem
BREG REC'D LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 24 IN TOTAL, 5 FOR 'UNK COLD THERAPY' ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND RPTR 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.
Description of Event or Problem
BREG REC'D LEGAL NOTICE OF FILED LAWSUITS EACH WITH MULTIPLE COMPLAINANTS, 24 IN TOTAL, 5 FOR 'UNK COLD THERAPY' ALLEGING "PERSONAL INJURY" AFTER USE OF COLD THERAPY. THE EXTENT OF THE "PERSONAL INJURY" IS UNK AND RPTR 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.