NEW IMAGE DRAINABLE POUCH

Additional Manufacturer Narrative

THE LOT NUMBER WAS PROVIDED, ENABLING A DEVICE HISTORY RECORD (DHR) REVIEW, WHICH WAS COMPLETED WITH NO ANOMALIES IDENTIFIED. HOWEVER, THE POUCH WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE CONDUCTED. A COMPLAINT HISTORY TREND ANALYSIS WAS PERFORMED FOR SIMILAR COMPLAINTS, AND NO ADVERSE TRENDS WERE OBSERVED. BASED ON THE INFORMATION AVAILABLE, A ROOT CAUSE COULD NOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER EXPERIENCED EFFLUENT LEAKAGE WHEN THE LOCK N ROLL CLOSURE OF THE HOLLISTER NEW IMAGE DRAINABLE POUCH UNROLLED. IT WAS REPORTED THAT THE END USER WEARS DEPENDS, WHICH ALSO COVERS THE POUCH, AND THE POUCH HAS BEEN OPENING, RESULTING IN CONTENTS LEAKING OUT INTO THE DEPENDS. IT WAS FURTHER REPORTED THAT THE LEAKAGE INTO HER DEPENDS ON LED TO A URINARY TRACT INFECTION (UTI), FOR WHICH SHE REQUIRED ANTIBIOTIC TREATMENT.