BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5002-KX-B

    MDR report key: 23696721 · Received December 2, 2025

    Report

    Report Number
    1316463-2025-00093
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 2, 2025
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    FRI
    UDI-DI
    00732094227314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE WELCH ALLYN MASTED SCALES ARE INTENDED TO BE USED BY CLINICIANS FOR WEIGHING PATIENTS UP TO 660 POUNDS (300 KG) FOR MODEL 5122, UP TO 880 POUNDS (400 KG) FOR MODELS 5002 AND 6002. MASTED SCALES CAN MAKE CONTACT WITH A PATIENT¿S HANDS AND FEET. CONTACT DURATION IS INTENDED TO BE LIMITED TO LESS THAN 30 SECONDS. THE CUSTOMER REFUSED TO RETURN THE DEVICE AND WAS PROVIDED WITH THE REPLACEMENT PART #S TO RESOLVE THE MALFUNCTION. CONTACT WITH EXPOSED ELECTRICAL WIRE CAN RESULT IN ELECTRICAL INJURY.

    Description of Event or Problem · 0

    CUSTOMER REPORTED POWER SUPPLY HAD EXPOSED WIRING. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2822936 5002-KX-B SCALE, STAND-ON, PATIENT FRI WELCH ALLYN, INC. 901109 00732094227314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown