NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT OSTOMY BARRIER

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. LOT NUMBER NOT PROVIDED SO DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED GENERALIZED REACTION TO THE BARRIER OF THE OSTOMY APPLIANCE CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER, WHO HAD ILEOSTOMY SURGERY WAS PUT IN THE HOLLISTER 14604 OSTOMY BARRIER IN THE HOSPITAL. THE END USER REPORTED THAT SHE STARTED TO HAVE A SKIN REACTION, SO THEY GAVE HER IV BENADRYL. SHE SAID SHE ASKED IF THEY COULD SWITCH HER TO A DIFFERENT BARRIER AND THEY SAID NO BECAUSE THAT WAS THE ONLY BARRIER THEY HAD; AND WAS CONSEQUENTLY SENT HOME IN THAT BARRIER. SHE REPORTED SHE HAD MORE OF A REACTION TO THE BARRIER AT HOME INCLUDING VERY RED SKIN UNDER THE FOOTPRINT OF THE BARRIER AND GENERALIZED HIVES. SHE SAID SHE NOTICED HER TONGUE WAS SWELLING SO SHE WENT TO THE ER WHERE SHE REPORTED THEY GAVE HER TWO DOSES OF HER EPIPEN FOR THE REACTION TO SUBSIDE. SHE SAID THEY THEN SWITCHED HER TO A DIFFERENT BRAND OF OSTOMY BARRIER, AND SHE IS NO LONGER HAVING A REACTION TO THE BARRIER.