NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER

Additional Manufacturer Narrative

END USER DID NOT SAVE DEVICE OR OTHER DEVICES FROM THAT LOT OF PRODUCT. END USER DOES NOT HAVE THE ABILITY TO TAKE PHOTOS ON HIS PHONE TO PROVIDE TO THE MANUFACTURER FOR REVIEW. DHR REVIEW CONDUCTED AND NO ISSUES IDENTIFIED. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. ROOT CAUSE OF THIS REPORTED ISSUE CANNOT BE DETERMINED BUT THE USER CUTTING THE BARRIER STOMA OPENING BIGGER SEEMS TO BE HELPING. WEIGHT NOT PROVIDED SO ESTIMATION USED.

Description of Event or Problem

IT WAS REPORTED THAT THE END USER HAD HIS COLOSTOMY SURGERY ON (B)(6) 2020. SINCE THEN, HE HAS EXPERIENCED 3-4 STOMA BLEEDS WHILE USING THE NEW IMAGE OSTOMY BARRIER. THE BLEEDING IS COMING FROM CUTS THAT HE DESCRIBES AS LITTLE NICKS ON THE STOMA. HE STATES THAT HE CUTS THE CUT-TO-FIT BARRIER VERY CAREFULLY AND MAKES SURE THERE ARE NO SHARP EDGES. HE REPORTS THAT HIS STOMA MOVES IN AND OUT A LITTLE. THE FIRST BLEED WAS WHILE HE WAS STILL IN THE HOSPITAL 2 DAYS AFTER SURGERY. HE IS USUALLY ABLE TO STOP THE BLEEDING HIMSELF BY APPLYING PRESSURE. ONE TIME, ON (B)(6) 2020, THE STOMA HAD CUTS AND WOULD NOT STOP BLEEDING. HE WENT TO THE ER WHERE THEY USED CHEMICAL CAUTERY (SILVER NITRATE) TO STOP THE BLEEDING. HE IS NOW CUTTING THE BARRIER STOMA OPENING LARGER AND HAS STOPPED TAKING BABY ASPIRIN. SINCE THEN, HE SAID IT IS DOING MUCH BETTER. HE WILL BE VISITING THE (B)(6) SOON.