MERIT DRAINAGE DEPOT¿

Additional Manufacturer Narrative

THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A LOT NUMBER WAS REPORTED, AND A REVIEW OF THE MANUFACTURING HISTORY RECORD IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE ACCOUNT ALLEGES THE VALVES ON THE DEVICE ARE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE FOUND. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND 3 SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED.