BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGIE PEARLS BED

    MDR report key: 21210570 · Received January 22, 2025

    Report

    Report Number
    MW5165072
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    November 8, 2024
    Report Date
    January 14, 2025
    Manufacturer
    SYNERGIE NEDERLAND BV
    Product Code
    INX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ARJO PEARLS BED HEADREST DESIGN INCLUDES A ZIPPER AND COVER. THE BASE OF THE ZIPPER IS COVERED BY A FOAM / SILICONE FLAP THAT INADEQUATELY COVERED THE ZIPPER. THIS ALLOWED THE ZIPPER TO COME INTO CONTACT WITH THE PT'S SKIN CAUSING FRICTION AND PRESSURE THAT CAUSED A WOUND. PREEXISTING WEIGHT LOSS, PT. VASCULAR DISEASE/POOR HEALING, WAS ADMITTED FOR EXISTING WOUNDS. UNK - BED / HEADREST RETURNED TO MFR AND DISTRIBUTOR. DISTRIBUTOR / EQUIPMENT OWNER ARJO INTL., 2349 W. LAKE ST, STE 250, ADDISON, IL 60101. MANUFACTURER SYNERGIE - STERREKROOSS 6, 4941 VZ, RAAMSDONKSVEER, NETHERLANDS. BED THERAPY DURATION ABOUT 4 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083661 SYNERGIE PEARLS BED BED, AIR FLUIDIZED INX SYNERGIE NEDERLAND BV

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other