NEW IMAGE

Description of Event or Problem

IT WAS REPORTED THAT AN OSTOMATE EXPERIENCED SKIN IRRITATION, REDNESS AND OOZING UNDER THE BARRIER AFTER USING THREE DIFFERENT HOLLISTER PRODUCTS FOR A PERIOD OF TIME. THIS IS THE THIRD OF THE 3 PRODUCTS, 11703 HOLLISTER NEW IMAGE BARRIER. IT WAS REPORTED THAT THE PATIENT TRIED USING OTHER OSTOMY PRODUCTS AND THE IRRITATION BECAME WORSE. THE PATIENT REPORTED EVENTUALLY EXPERIENCING EXTREME ITCHINESS ON HIS ARMS, LEGS, CHEST AND BACK, WITH LITTLE BUMPS. THE PATIENT ALSO REPORTED HE WENT TO THE WOUND CARE NURSE AND WAS PRESCRIBED TRIAMCINOLONE CREAM AND A DIFFERENT BARRIER PRODUCT. IT WAS ADDITIONALLY REPORTED THAT THE REACTION CONTINUED AND THEN HE DEVELOPED A GENERALIZED REACTION WITH HIVES AND ITCHING OVER MOST OF HIS BODY. THE PATIENT REPORTED HE WENT TO THE URGENT CARE CENTER AND RECEIVED A STEROID SHOT AND A STEROID DOSE PACK AFTER WHICH HE FELT BETTER. HOLLISTER HAS ADVISED THE PATIENT TO SEEK ATTENTION FROM HIS HEALTH CARE PROFESSIONALS BEFORE USING THE HOLLISTER BARRIER AGAIN.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS NOT CONDUCTED AS THE LOT NUMBER WAS NOT PROVIDED. IN VIVO SKIN SENSITIZATION TESTING IS PERFORMED TO IDENTIFY THE POTENTIAL RISK OF AN ALLERGIC RESPONSE. SOME INDIVIDUALS MAY STILL BE SENSITIVE TO A SPECIFIC MATERIAL THAT HAS MET ALL SENSITIZATION TEST REQUIREMENTS, AND THE SEVERITY OF THE REACTION CANNOT BE PREDICTED. ONLY THE DI OF THE UDI INFORMATION WAS PROVIDED BECAUSE THE LOT NUMBER WAS NOT KNOWN.