NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER

Additional Manufacturer Narrative

LOT NUMBER NOT KNOWN SO DHR REVIEW IS NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. END USER STATED THAT THE ISSUE WAS THAT THE HOLLISTER PRODUCT THAT WORKED WELL FOR HER WAS NOT AVAILABLE FOR A TIME THROUGH HER SUPPLIER. THE PRODUCT WITH WHICH THEY SUBSTITUTED DID NOT WORK WELL FOR HER AND ALLOWED LEAKAGE. ONCE SHE WAS BACK IN HER ORIGINAL HOLLISTER PRODUCT, THE LEAKAGE RESOLVED.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER WHO HAD BEEN USING HOLLISTER OSTOMY BARRIERS FOR 25 YEARS WAS RECENTLY SENT A DIFFERENT HOLLISTER BARRIER BY HER SUPPLIER. THE SUPPLIER SAID THEY DID NOT HAVE HER PREFERRED SKU AVAILABLE. SHE USED THE DIFFERENT BARRIER BUT IT ALLOWED EFFLUENT LEAKAGE. THE LEAKAGE EVENTUALLY LED TO SKIN IRRITATION ON THE BOTTOM HALF OF HER PERISTOMAL SKIN. SHE NEEDED MEDICAL TREATMENT FOR THE SKIN IRRITATION IN THE FORM OF PRESCRIPTION STEROID CREAM. SHE HAS ONLY BEEN USING THE STEROID CREAM FOR 2 DAYS NOW SO SHE IS NOT SURE IF IT IS CLEARING UP THE SKIN IRRITATION YET. IN THE MEANTIME, THE SUPPLIER HAD HER PREFERRED HOLLISTER BARRIER AVAILABLE AGAIN AND SUPPLIED HER WITH THOSE TWO WEEKS AGO. SHE IS BACK TO USING HER PREFERRED HOLLISTER BARRIER AND THE LEAKAGE HAS NOW STOPPED.