BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZUI UTERINE INJECTOR 2.0MM

    MDR report key: 1883217 · Received October 20, 2010

    Report

    Report Number
    1216677-2010-00006
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 18, 2010
    Manufacturer
    COOPERSURGICAL
    Product Code
    LKF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN RETURNED 8 INDIVIDUAL DEVICES IN SEALED POUCHES WITH THE SAME LOT NUMBER AS THE DEVICE ALLEGEDLY USED DURING THE ADVERSE EVENT. UPON ANALYSIS, IT WAS CONFIRMED THAT ALL 8 UNITS HAD BROKEN TIPS. THE BREAKAGE OCCURRED NEAR THE PROXIMAL BALLOON BOND LINE. INTERACTION WITH OUR CONTRACT MFR SUGGESTED THE ADHESIVE USED TO BOND THE BALLOON COULD RESULT IN BRITTLENESS OF THE TUBING. A CAPA HAS BEEN ISSUED FOR THIS NONCONFORMITY AND WE ARE CURRENTLY VALIDATING A RECOMMENDED ALTERNATIVE ADHESIVE. THERE HAVE BEEN NO CHANGES TO MATERIAL OR THE ASSEMBLY PROCESS OVER THE LIFE OF THE ZUI UTERINE INJECTOR. (B)(4).

    Description of Event or Problem · 1

    ZUI UTERINE INJECTOR WAS USED ON AND BROKE INSIDE PT, WHO WILL NOW REQUIRE MORE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZUI UTERINE INJECTOR 2.0MM NONE LKF COOPERSURGICAL 87835

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention