BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 19658002 · Received July 2, 2024

    Report

    Report Number
    3006116468-2024-00001
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 1, 2024
    Manufacturer
    MICROTEK MEDICAL B.V.
    Product Code
    KME
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LIFT SHEET FROM OR-02 TORE WHILE POSITIONING THE PATIENT. SHE WAS IN A LITHOTOMY POSITION AND WEIGHED 158 LBS. THIS HAPPENED IN THE OR WHEN MOVING HER DOWN TO THE END OF THE BED. THEY WERE ABLE TO GRAB UNDER THE PATIENT TO MOVE HER. SHE WAS NOT HARMED. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571191 MICROTEK PATIENT TRANSFER SHEET KME MICROTEK MEDICAL B.V. LFTSH34N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown