InjuryILO
UNKNOWN PRODUCT
Received May 10, 2011 · Event occurred Apr 13, 2011
Report 1313850-2011-00103 · MDR key 2095287
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Tissue Breakdown
Narrative
Additional Manufacturer Narrative
EXACT DEVICE TYPE USED IN REPORTED EVENTS IS UNKNOWN; THEREFORE, NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT OUT OF 29 CASES IN WHICH THE CUSTOMER HAS USED GAYMAR TEMP THERAPY, 6 PATIENTS HAVE ALLEGEDLY EXPERIENCED SKIN BREAKDOWN.