BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVER, BARRIER, PROTECTIVE

    MDR report key: 17324551 · Received July 14, 2023

    Report

    Report Number
    17324551
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 21, 2023
    Report Date
    June 27, 2023
    Manufacturer
    VITAL CARE INDUSTRIES, LLC
    Product Code
    MMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    GENERAL PURPOSE PROBE COVER 5" BY 48" EXPIRES [REDACTED DATE], REF# VPC0548, LOT# V140222.AT THE END OF KIDNEY BIOPSY THE ULTRASOUND TECH NOTED PROBE COVER NOT INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692897 COVER, BARRIER, PROTECTIVE MMP VITAL CARE INDUSTRIES, LLC V140222

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA Male