BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE PINK PAD XL ADVANCED TRENDELENBURG POSITIONING SYSTEM

    MDR report key: 10983074 · Received December 10, 2020

    Report

    Report Number
    10983074
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    December 2, 2020
    Report Date
    December 7, 2020
    Manufacturer
    XODUS MEDICAL, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A DA VINCI PROSTATECTOMY AND UMBILICAL HERNIA REPAIR. PATIENT WAS POSITIONED ON "PINK PAD" TO PREVENT SLIDING WHILE PATIENT IN STEEP TRENDELENBURG. PATIENT STILL SLID DOWN AND ACTUALLY OFF TABLE APPROX. 1.5 INCHES. THIS CREATED TENSION ON LEGS, WHICH WERE SECURED IN STIR-UPS AND PULLED ON TROCAR SITES, WHICH HAVE THE OPERATIVE INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452628 THE PINK PAD XL ADVANCED TRENDELENBURG POSITIONING SYSTEM SUPPORT, PATIENT POSITION CCX XODUS MEDICAL, INC. 201111B

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA