BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMLINE

    MDR report key: 8114865 · Received November 29, 2018

    Report

    Report Number
    8114865
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    November 13, 2018
    Report Date
    November 16, 2018
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    OEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DISCOVERED APPROXIMATELY 12 DISPOSABLE BLOOD PRESSURE CUFFS THAT DID NOT FUNCTION. TEARS WERE NOTED BETWEEN THE CUFF AND THE RUBBER TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953855 TRIMLINE DISPOSABLE BP CUFF OEA WELCH ALLYN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1