BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK-SWARTZ DOPPLER FLOW PROBE STANDARD CUFF

    MDR report key: 11153989 · Received January 12, 2021

    Report

    Report Number
    11153989
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Date of Event
    November 24, 2020
    Report Date
    December 29, 2020
    Manufacturer
    COOK VANDERGRIFT INC.
    Product Code
    JOP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FRAGMENT OF WIRE BROKE OFF DURING REMOVAL AND NOT OBVIOUS TO PROVIDER WHO REMOVED IT. ITEM DISCOVERED SEVERAL DAYS LATER RETAINED IN THE PATIENT. LEFT IN PATIENT DUE TO RISK OF REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51097 COOK-SWARTZ DOPPLER FLOW PROBE STANDARD CUFF TRANSDUCER, ULTRASONIC JOP COOK VANDERGRIFT INC. G21363 N172688

    Patients

    Seq Age Sex Outcome Treatment
    1 27375 DA