BEUDAMED
    FDA Adverse Event Other Summary report: N

    LACRICATH

    MDR report key: 488845 · Received October 8, 2003

    Report

    Report Number
    488845
    Event Type
    Other
    Date Received
    October 8, 2003
    Date of Event
    September 1, 2002
    Report Date
    December 1, 2002
    Manufacturer
    ATRION MEDICAL PRODUCTS [INC.]
    Product Code
    HNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LACRICATH DUCT CATHETER DID NOT DEFLATE COMPLETELY CAUSING DIFFICULTY IN THE PROCEDURE. THE MD WAS ABLE TO COMPLETE THE PROCEDURE DESPITE A DEFECT IN THIS SINGLE USE PRODUCT. SURGEON STATES NO COMPLICATIONS DUE TO DEVICE MALFUNCTION. [IT IS NOT KNOWN IF THE PROBLEM WAS WITH THE BALLOON, THE DEVICE THAT LOCKS AND SWITCHES FROM INFLATE TO DEFLATE, OR THE VACUUM DEVICE. AND, IT'S UNKNOWN IF THE PHYSICIAN WAS ABLE TO INFLATE AND DEFLATE THE BALLOON ENOUGH TO COMPLETE ALL THE INTERMEDIATE PARTS OF THE PROCEDURE. THE DEVICE WAS SAVED AND SENT BACK TO THE MANUFACTURER. ALL OTHER DEVICES WITH THE SAME LOT NUMBER WERE PULLED FROM THE SHELVES AND ALSO RETURNED TO THE MANUFACTURER. THE QUALITY CONTROL REPRESENTATIVE FROM THE MANUFACTURER CONTACTED THE PHYSICIAN AFTER THE INCIDENT.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACRICATH [LACRIMAL] DUCT CATHETER HNW ATRION MEDICAL PRODUCTS [INC.] LDC213 AM031302-1

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other