BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL EQUIPMENT ROLL STAND

    MDR report key: 13018103 · Received December 16, 2021

    Report

    Report Number
    3006260740-2021-05321
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    December 8, 2021
    Report Date
    December 10, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    IYO
    UDI-DI
    00801741124693
    PMA / PMN Number
    K152554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A HISTORY REVIEW OF SERIAL NUMBER (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS SERIAL NUMBER.

    Description of Event or Problem · 0

    MER STAND HAS A BENT CASTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916507 MEDICAL EQUIPMENT ROLL STAND SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO C.R. BARD, INC. (BASD) -3006260740 N/A DYFVZZ001 00801741124693

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other