BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRENDELENBURG POSITIONING KIT

    MDR report key: 25080641 · Received May 5, 2026

    Report

    Report Number
    25080641
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 22, 2026
    Report Date
    April 22, 2026
    Manufacturer
    THE SOULE CO., INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN PATIENT WAS PLACED IN TRENDELENBURG THE PATIENT SLIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593879 TRENDELENBURG POSITIONING KIT SUPPORT, PATIENT POSITION CCX THE SOULE CO., INC. TP 3000E-S-NBDS-AP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other