BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAFFLE CUSHION

    MDR report key: 21079059 · Received January 6, 2025

    Report

    Report Number
    21079059
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    November 20, 2024
    Report Date
    November 26, 2024
    Manufacturer
    EHOB, INC.
    Product Code
    FMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE TOOK WAFFLE CUSHION TAKEN OUT OF PACKAGING TO USE FOR PATIENT AND WAFFLE CUSHION WAS DEFLATED. ANOTHER CUSHION OBTAINED WITHOUT ISSUE. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, WAFFLE CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO (RETRACTED EMAIL ADDRESS) ON (RETRACTED DATE). PRODUCT AVAILABLE FOR RETURN TO MANUFACTURER WITH MAILING LABELS PROVIDED BY MANUFACTURER. EQUIPMENT RETURNED TO MANUFACTURER ON (RETRACTED DATE) VIA UPS GROUND (RETRACTED TRACKING NUMBER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064256 WAFFLE CUSHION PRESSURE REDUCTION CUSHION FMP EHOB, INC. 428122B

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female