BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARIATRIC WAFFLE CUSHION

    MDR report key: 18989988 · Received March 28, 2024

    Report

    Report Number
    18989988
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 6, 2024
    Manufacturer
    EHOB INC
    Product Code
    KIC
    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

    PATIENT (PT) ADMITTED TO ACUTE CARE AND UNDERWENT LEFT TOTAL HIP REPLACEMENT. SEAT CUSHION INITIATED NEXT DAY. PT WEIGHED 209 LBS. PT WAS ADMITTED TO SNF (SKILLED NURSING FACILITY) TWO DAYS AFTER SURGERY. WAFFLE CUSHION FOUND DEFLATED FOLLOWING DAY. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, BARIATRIC WAFFLE CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO '[email protected]'. EQUIPMENT AVAILABLE FOR RETURN TO MANUFACTURER FOR INVESTIGATION. AWAITING RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720338 BARIATRIC WAFFLE CUSHION CUSHION, FLOTATION KIC EHOB INC 2200WC 332112D

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female