FLEXIPAC

Description of Event or Problem

PT MISUSED THE COLD COMPRESS PRODUCT BY PLACING IT IN A COMPETITORS WRAP, THEN PLACING THE UNINTENDED SIDE OF THE WRAP AGAINST HER SKIN THAT DID NOT PROVIDE INSULATING PROPERTIES TO PREVENT FROSTBITE TO THE SKIN. THE INSTRUCTION WRITTEN ON THE COLD PACK ITSELF WARNS TO ONLY USE THE MFR BRAND WRAP WITH THE COLD COMPRESS.

Additional Manufacturer Narrative

THE PT MISUSED THE COLD COMPRESS PRODUCT BY INSERTING IT INTO A COMPETITOR'S SEWN WRAP/SLEEVE, AND APPLYING THE WRONG SIDE TO HER SKIN RESULTING IN FROSTBITE TO THE SKIN. ADD'L LOT# 051207.