13982000 AB BNDR 12" UNIV 46-62

Description of Event or Problem

BINDER MAY HAVE CAUSED A RASH ON THE PATIENT. THIS WAS PUT ON PATIENT FOLLOWING SURGERY TO IMPLANT A PUMP. THE AREA COVERED BY THE INCISION SITE DRESSING WAS NOT AFFECTED BUT ALL OTHER AREAS THAT THE BINDER TOUCHED BROKE OUT IN RED WATERY BLISTERS. THE PRODUCT WAS REMOVED, HYDROCORTIZONE CREAM WAS APPLIED AND A COTTON CORSET WAS PUT ON THE PATIENT. THESE PRODUCTS WERE SOLD TO THE HOSPITAL WHO SUPPLIED THEM TO THE PAIN CLINIC WHICH IS PART OF THE HOSPITAL. THE HOSPITAL WAS TOLD THAT THESE PRODUCTS CHANGED TO LATEX SAFE 6 MONTHS AGO. THE LOT NUMBER LISTED CAME FROM THE INVENTORY ON HAND AT THE HOSPITAL CURRENTLY, THEREFORE IT MAY BE THE WRONG LOT NUMBER FOR THE AFFECTED DEVICE.