PREMIER

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED DUE TO LACK OF LOT NUMBER INFORMATION. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED IRRITATION AND WOUNDS UNDER THE OSTOMY BARRIER CANNOT BE DETERMINED. ONLY THE DI OF THE UDI INFORMATION IS KNOWN DUE TO LACK OF LOT NUMBER INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT AN END USEDR WAS PLACED IN HOLLISTER PREMIER OSTOMY POUCHING SYSTEM 8958 AFTER SURGERY AND WENT TO A REHAB TO RECOVER. IT WAS REPORTED THAT WHILE IN REHAB, WHEN HER OSTOMY POUCH WAS FULL, THE STAFF, BEING UNDERSTAFFED, DID NOT TEND TO HER OSTOMY NEEDS PROMPTLY. SHE REPORTED THAT IT LED TO EFFLUENT LEAKAGE UNDER THE BARRIER WHICH LED TO SKIN IRRITATION AND PERISTOMAL SKIN WOUNDS. IT WAS FURTHER REPORTED THAT SHE WAS HOSPITALIZED TO RECEIVE WOUND CARE FOR THESE WOUNDS AND IS SCHEDULED FOR A STOMAL REVERSAL NEXT WEEK.