BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODEX

    MDR report key: 20125643 · Received August 30, 2024

    Report

    Report Number
    MW5159158
    Event Type
    Injury
    Date Received
    August 30, 2024
    Report Date
    August 28, 2024
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MATTRESS AUDIT PERFORMED IN COMPLIANCE WITH VHA. FOUND TWO ULTRASOUND TABLES WITH FOAM COVERINGS COMPROMISED. SMALL SLITS ON SIDE OF ULTRASOUND TABLES FOAM COVERINGS. REFERENCE REPORT: MW5159159.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056218 BIODEX TABLE, OPERATING-ROOM, AC-POWERED FQO BIODEX MEDICAL SYSTEMS, INC. 058-726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention