NEW IMAGE FLEXTEND CUT TO FIT BARRIER

Additional Manufacturer Narrative

THE LOT NUMBER IS NOT KNOWN SO THE DEVICE HISTORY RECORD REVIEW IS NOT POSSIBLE. THE DEVICE NOT SAVED FOR RETURN SO DEVICE EVALUATION NOT POSSIBLE. THE TREND ANALYSIS CONDUCTED SHOWED NO ADVERSE TRENDS. ESTIMATES USED FOR PATIENT'S WEIGHT BECAUSE ACTUAL WEIGHT NOT PROVIDED. THE ROOT CAUSE OF THE REPORTED SKIN ISSUE CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER EXPERIENCED A LEAK UNDER THE BARRIER OF HIS HOLLISTER NEW IMAGE BARRIER IN MID-NOVEMBER. HE THEN DEVELOPED AN ALLERGIC REACTION TO THE TAPE ADHESIVE AND A YEAST INFECTION UNDER THE BARRIER ALONG WITH ITCHING. HE TRIED OVER THE COUNTER MEDICINE BUT IT DID NOT WORK. IN THE FIRST PART OF JANUARY HE HAD A VIRTUAL VISIT WITH HIS NURSE WHO PRESCRIBED NYSTATIN AND THEN TRIAMCINOLONE ACETONIDE. END USER WOULD ALSO TAKE BENADRYL FOR THE ITCH. THE AREA WAS CLEARING UP BY NOT USING THE BARRIER BUT WHEN HE STARTED USING THE BARRIER AGAIN, THE RASH RETURNED. HOLLISTER WILL SEND OUT A DIFFERENT BARRIER PRODUCT FOR HIM TO SAMPLE.