BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40695 THE PINK PAD XL - ADVANCED TRENDELENBURG POSITIONING KIT - BIODEGRADABLE

    MDR report key: 22318659 · Received June 24, 2025

    Report

    Report Number
    22318659
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 23, 2025
    Report Date
    June 10, 2025
    Manufacturer
    XODUS MEDICAL, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS PLACED ON THE XODUS MEDICAL "THE PINK PAD" IN PREPARATION FOR POSITIONING FOR SURGERY. SURGERY STARTED IN A LOW LITHOTOMY TRENDELENBURG POSITION. UPON REPOSITIONING OF TABLE OUT OF TRENDELENBURG AND PRIOR TO DOCKING THE SURGICAL ROBOT IT APPEARED THAT THE PATIENT SLID WHILE IN THE TRENDELENBURG POSITION. PATIENT POSITIONING WAS REEVALUATED UNDER THE SURGICAL DRAPES AND IT WAS DETERMINED THAT PATIENT HAD SLID APPROXIMATELY 1 FOOT WITH BUTTOCKS COMPLETELY OFF THE BED. THE PINK PAD APPEARED TO BE COMING APART AND OR SHREDDING UNDER PATIENT. THE PATIENT WAS SUBSEQUENTLY REPOSITIONED USING THE PINK PAD LIFT SHEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941996 40695 THE PINK PAD XL - ADVANCED TRENDELENBURG POSITIONING KIT - BIODEGRADABLE SUPPORT, PATIENT POSITION CCX XODUS MEDICAL, INC. 40695 250306

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female