BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40580 - THE PINK PAD - ADVANCED TRENDELENBURG POSITIONING KIT

    MDR report key: 21066051 · Received January 3, 2025

    Report

    Report Number
    21066051
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 23, 2024
    Report Date
    December 24, 2024
    Manufacturer
    XODUS MEDICAL, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PINK PAD PLACED ONTO OPERATING ROOM TABLE. IT WAS OBSERVED THAT AN INSECT WAS MADE INTO THE PAD ON WHITE STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434282 40580 - THE PINK PAD - ADVANCED TRENDELENBURG POSITIONING KIT SUPPORT, PATIENT POSITION CCX XODUS MEDICAL, INC. 40580 241126

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female