BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT WAFFLE HEEL PROTECTOR

    MDR report key: 15804226 · Received November 16, 2022

    Report

    Report Number
    15804226
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 5, 2022
    Report Date
    November 9, 2022
    Manufacturer
    EHOB, INC.
    Product Code
    FMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN GOT A BRAND-NEW WAFFLE HEEL PROTECTOR FOR A PATIENT AND BOTH THE SIDES WERE DEFLATED. ITEM IS LOCATED IN ROOM 5615 WITH THE ASSISTANT PATIENT SERVICE MANAGER. MANUFACTURER RESPONSE FOR WAFFLE HEEL PROTECTOR, WAFFLE HEEL PROTECTOR (PER SITE REPORTER) ADDED TO TRACKER FOR TRENDING, 10/25 RETRIEVING. EHOB REG, MANUFACTURER WILL SEND IN A REPLACEMENT PRODUCT DIRECT. MATT WILL WORK TO RETRIEVE THE DEFECTIVE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783062 FOOT WAFFLE HEEL PROTECTOR PROTECTOR, SKIN PRESSURE FMP EHOB, INC. EHO345CX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown