ACE REUSABLE COLD COMPRESS
Received Jun 20, 2008 · Event occurred May 23, 2008
Report 2243072-2008-00043 · MDR key 1063125
Device
Product problems
- Fluid/Blood Leak
Patient
UNK
- Blister(s)
- Skin Discoloration
- Tingling
- Chemical Exposure
- Treatment with medication(s)
Narrative
Description of Event or Problem
CONSUMER REPORTED HAD SPRAIN OF LEFT CALF AND AFTER PLACING COMPRESS IN FREEZER FOR 30 MINUTES HE APPLIED ACE REUSABLE COLD COMPRESS SECURING IT WITH VELCRO WARP. IN ABOUT 30 MINUTES OF APPLICATION, CONSUMER STARTED TO FEEL TINGLING IN THE CALF AREA. WHEN COMPRESS WAS REMOVED, A DARK SPOT WAS LEFT ON SKIN AND A LEAKAGE WAS ALSO OBSERVED. CONSUMER WAS SELF TREATED WITH NEOSPORIN. WHEN BLISTER BROKE THROUGH, CONSUMER WENT TO ER AND HE ALSO SCHEDULED FOR A FOLLOW-UP WITH HIS PHYSICIAN.
Additional Manufacturer Narrative
NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNKNOWN. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.