PREMIER

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE LOT NUMBER WAS NOT PROVIDED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF THE REPORTED STOMA LACERATION IS RELATED TO THE END USER USING THE WRONG SIZED PRODUCT. THIS HAS SINCE BEEN ADDRESSED BY THE CLINICIAN. ONLY THE DI PORTION OF THE UDI INFORMATION IS KNOWN DUE TO LACK OF LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER WAS USING A PRE CUT 32MM HOLLISTER OSTOMY POUCHING SYSTEM AND WAS STRETCHING IT WITH HIS FINGERS TO MAKE IT LARGE ENOUGH TO FIT OVER THE STOMA EVEN THOUGH IT WAS TOO SMALL. IT WAS REPORTED THAT THE END USER CUT HIS STOMA BY DOING THIS AND ENDED UP IN THE ER. IT WAS FURTHER REPORTED THAT FIRST THE OSTOMY CLINIC TRIED USING SILVER NITRATE ON THE WOUND, WHICH CAUSED THE END USER TO PASS OUT. IT WAS REPORTED THAT THE END USER WAS THEN ADMITTED TO THE ER WHERE THEY STITCHED THE WOUND CLOSED. A POUCHING SYSTEM WITH A LARGER PRE CUT OPENING SIZE HAS SINCE BEEN ORDERED.