ABDOMINAL BINDER

Description of Event or Problem

PATIENT DEVELOPED ITCHY LOCALIZED RAISED RED RASH ON BACK AND ABDOMEN REQUIRING TREATMENT WITH HYDROCORTIZONE CREAM BID AND BENADRYL PO AS NEEDED.THIS FACILITY HAS HAD ONGOING ISSUES WITH THIS DEVICE OVER THE LAST YEAR. RASHES HAVE DEVELOPED AFTER THE ABDOMINAL BINDER IS PLACED. PATIENTS IN ALL AREAS OF THE FACILITY WHERE THE PRODUCT IS USED HAVE BEEN AFFECTED. THERE IS NO APPARENT VISUAL DEFECT TO THE DEVICE. THE RASH DEVELOPS WITHIN 24 HOURS AFTER PLACEMENT ON THE PATIENT. AFFECTED PATIENTS ARE NOT ALLERGIC TO LATEX AND HAVE NO PREVIOUSLY REPORTED ALLERGIES. SOME PATIENTS HAVE REQUIRED MEDICAL INTERVENTION FOR THE RASH. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. CONTRIBUTING FACTORS FOR THE RASH HAVE NOT BEEN ABLE TO BE DETERMINED. THE DEVICES ARE STORED IN TEMPERATURE CONTROLLED ENVIRONMENTS AND ARE SEALED IN THEIR INDIVIDUAL PACKAGES UNTIL NEEDED. MULTIPLE LOT NUMBERS ARE INVOLVED.======================MANUFACTURER RESPONSE FOR ABDOMINAL BINDER 9 IN SMALL/ MEDIUM, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================NOTIFIED DEROYAL REPRESENTATIVE AND HE PLANS TO PICK UP FOR INVESTIGATION.