DEROYAL

Description of Event or Problem

THE HOSPITAL REPORTED THAT THEY HAVE HAD MULTIPLE EVENTS WITH THE ABDOMINAL BINDER CAUSING A RASH ON STOMACH IN THE LAST 6 MONTHS. PRODUCT STATES LATEX FREE. THE FACILITY REPORTS THAT THIS TYPE OF REACTION HAS BEEN SEEN IN PATIENTS WITH C-SECTIONS AS WELL AS VAGINAL DELIVERIES; THUS, THE STAFF DOES NOT BELIEVE THAT THERE IS A REACTION TO THE SKIN PREP USED FOR C-SECTION DELIVERIES SINCE THE PREP IS NOT USED IN VAGINAL DELIVERY. ALSO, THE REACTION OCCURS ON AREAS WHERE SKIN PREP WAS NOT USED. PATIENTS WITH AND WITHOUT KNOWN ALLERGIES HAVE BEEN AFFECTED.

Additional Manufacturer Narrative

DEROYAL: THE BILL OF MATERIAL FOR THE REPORTED DEVICE WAS REVIEWED AND NO MATERIAL CHANGES HAVE BEEN MADE. THE ABDOMINAL BINDER IS NOT MADE WITH NATURAL RUBBER LATEX. A ROOT CAUSE COULD NOT BE DETERMINED.