BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITTICH NITINOL STONE BASKET

    MDR report key: 7118139 · Received December 14, 2017

    Report

    Report Number
    1820334-2017-04135
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    October 5, 2016
    Report Date
    December 14, 2017
    Manufacturer
    COOK VASCULAR INC
    Product Code
    LQR
    UDI-DI
    00827002058774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL_(B)(4), COMPLIANT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    THE BASKET BAR BROKE. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899091 WITTICH NITINOL STONE BASKET LQR DISLODGER, STONE BILIARY LQR COOK VASCULAR INC 00827002058774

    Patients

    Seq Age Sex Outcome Treatment
    1