ABDOMINAL BINDER

Description of Event or Problem

PATIENT DEVELOPED RASH ON ABDOMEN WHERE ABDOMINAL BINDER WAS LOCATED. THIS FACILITY HAS HAD ONGOING ISSUES WITH THIS DEVICE. MULTIPLE PATIENTS HAVE BEEN INVOLVED OVER APPROXIMATELY 8 MONTHS. PATIENTS WHO HAVE HAD C-SECTIONS AND THOSE WHO HAVE HAD VAGINAL DELIVERIES HAVE BEEN AFFECTED. THE FACILITY DOES NOT KNOW WHY THIS IS OCCURRING. SOME PATIENTS HAVE REQUIRED MEDICAL INTERVENTION FOR THE RASH THAT HAS DEVELOPED. PATIENTS WITH AND WITHOUT KNOWN ALLERGIES HAVE BEEN AFFECTED.====================== MANUFACTURER RESPONSE FOR SMALL/MEDIUM ABDOMINAL BINDER 9 INCH, (BRAND NOT PROVIDED) (PER SITE REPORTER).====================== LEFT A MESSAGE AND AWAIT A CALL BACK TO RETURN TO MANUFACTURER.