BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAFFLE HEEL PROTECTORS

    MDR report key: 17143564 · Received June 15, 2023

    Report

    Report Number
    MW5118434
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    June 4, 2023
    Report Date
    June 13, 2023
    Manufacturer
    EHOB INC.
    Product Code
    FMP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT DEVELOPED LEFT POSTERIOR HEEL DECUBITIS ULCER ON THE LEFT HEEL POTENTIALLY DUE TO THE WAFFLE BOOT THAT THE PATIENT WAS WEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709506 WAFFLE HEEL PROTECTORS PROTECTOR, SKIN PRESSURE FMP EHOB INC. 345CX 23491BA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention