BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUV

    MDR report key: 12404694 · Received September 1, 2021

    Report

    Report Number
    12404694
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    July 27, 2021
    Report Date
    August 11, 2021
    Manufacturer
    CEGA INNOVATIONS, INC.
    Product Code
    FMR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE GYNECOLOGY (GYN) SURGEONS HAVE REPORTED CONCERNS THAT THE PATIENTS ARE SLIDING WHEN PLACED IN TRENDELENBURG POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306795 REMUV DEVICE, TRANSFER, PATIENT, MANUAL FMR CEGA INNOVATIONS, INC. MV800 CEGA 2020003

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA