BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE SMARTGUARD GEL HEEL CUP

    MDR report key: 22166115 · Received June 9, 2025

    Report

    Report Number
    22166115
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    May 13, 2025
    Report Date
    June 3, 2025
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC
    Product Code
    FMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT SUSTAINED PRESSURE INJURIES DURING PROLONGED OR PROCEDURE (OPEN HEART SURGERY > 12 HOURS) DESPITE PROPER POSITIONING WITH GEL HEEL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632988 ADVANCE SMARTGUARD GEL HEEL CUP PROTECTOR, SKIN PRESSURE FMP ADVANCE MEDICAL DESIGNS, INC GEL-HC

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male