NEW IMAGE CONVEX FLEXTEND CTF WITH TAPE

Additional Manufacturer Narrative

END USER DID NOT SAVE DEVICE FOR EVALUATION. END USER DOES NOT HAVE INTERNET SO PHOTOS COULD NOT BE PROVIDED TO THE MANUFACTURER FOR REVIEW. LOT NUMBER NOT PROVIDED SO DHR REVIEW COULD NOT BE CONDUCTED. TREND DATA REVIEWED AND THIS IS THE ONLY COMPLAINT OF BLEEDING FROM THE STOMA FOR THIS SKU OVER THE LAST 3 YEARS. NO MEDICAL PROFESSIONAL STATED THAT THE BLOOD FROM THE STOMA HAD ANYTHING TO DO WITH THE HOLLISTER OSTOMY BARRIER. ROOT CAUSE OF THIS REPORTED ISSUE CANNOT BE DETERMINED. WEIGHT NOT PROVIDED SO ESTIMATION USED.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER HAS BEEN USING THE HOLLISTER CUT-TO-FIT OSTOMY BARRIER SINCE 2014. FOR OVER THE PAST 2 YEARS, SHE WOULD OCCASIONALLY EXPERIENCED SMALL AMOUNTS OF BLEEDING FROM HER STOMA, WHICH INCREASED ABOUT A YEAR AGO WHEN SHE WAS PUT ON A SERIES OF BLOOD THINNERS. THE BLEEDING WOULD STOP WHEN SHE WOULD DAB THE AREA WITH A TISSUE. SHE COULD NOT TELL WHERE THE BLEEDING WAS COMING FROM. HER DOCTOR, WHILE CONDUCTING HER COLONOSCOPY, USED CHEMICAL CAUTERY ON AREAS OF HER STOMA WHICH MAY HAVE BEEN BLEEDING. THE CAUTERY WAS DONE AGAIN DURING HER FOLLOW UP APPOINTMENT. NO DOCTOR HAS INDICATED THAT THE BLEEDING WAS FROM HER OSTOMY BARRIER. SHE DENIES ANY MALFUNCTION OF THE BARRIER. SHE CUTS THE BARRIER OPENING SO IT IS SMOOTH.