NYLATEX 2 1/2X36 PKG OF 3

Description of Event or Problem

CUSTOMER RECEIVED A SEVERE RASH AFTER WEARING A NYLATEX BAND. THE CUSTOMER WROTE BY LETTER: "I DEVELOPED A SEVERE RASH DIRECTLY UNDER THE BAND. IT WAS SEVERE ENOUGH THAT I HAD TO VISIT A DERMATOLOGIST FOR A FINAL CURE. WHAT IS PUZZLING TO ME, IS THAT I HAVE WORN THE SAME BELTS FOR SEVERAL YEARS WITH ABSOLUTELY NO PROBLEM. I ADMIT THAT I SHOULD HAVE WRITTEN SOONER BUT, IS IT POSSIBLE THAT SOME TYPE OF NEW INGREDIENT HAS BEEN ADDED TO THE COMPOSITION OF THESE BELTS. WE ARE ENCLOSING ONE OF THEM, AND IF YOU NEED AN OLD ONE TO COMPARE IT WITH, PLEASE LET ME KNOW". THE CUSTOMER USES THE WRAP TO HOLD TISSUE IN PLACE IN THE ABDOMEN AREA. THE LOSE TISSUE IS A RESULTANT OF THE CUSTOMER'S ABDOMINAL BOWEL REMOVAL SYSTEM. THE CUSTOMER WEARS THE WRAP CONTINUOUSLY AROUND HIS ABDOMEN.

Additional Manufacturer Narrative

THE CUSTOMER CONFIRMED THAT HE HAD A SIMILAR RASH APPROXIMATELY 10 MONTHS AGO. BOTH RASHES ENCOMPASSED THE CIRCUMFERENCE OF HIS ABDOMEN AND THE WIDTH OF THE WRAP. IN THE MOST RECENT EVENT, THE CUSTOMER SOUGHT MEDICAL ATTENTION FROM A DERMATOLOGIST. THE DERMATOLOGIST PRESCRIBED PREDNISONE AND OINTMENT. THE RASH REPORTEDLY CLEARED UP AFTER 5 TO 10 DAYS. THE CUSTOMER CONFIRMED THAT THERE HAD BEEN NO CHANGE IN HYGIENE PRODUCTS, TO INCLUDE COLOGNE. THE DIET DOES NOT VARY EXTENSIVELY. SOME OF THE MEDICATION FOR THE CUSTOMER HAD CHANGED PRIOR TO THE EVENT. THE CUSTOMER EXPRESSED THAT THESE EVENTS DID NOT CONTRIBUTE TO THE EVENT. THE CUSTOMER CONTINUES TO USE THE WRAPS. THE WRAP WAS EVALUATED. THE WRAP APPEARED IN GOOD CONDITION. NO OTHER PATIENT EVENTS FOR THIS PRODUCT PART NUMBER IS KNOWN.