BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200WC BARIATRIC WAFFLE CUSHION

    MDR report key: 18855239 · Received March 7, 2024

    Report

    Report Number
    18855239
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 21, 2024
    Report Date
    February 22, 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 SNF (SKILLED NURSING FACILITY) ON [DATE REDACTED]. PT. WEIGHED 275 LBS. WAFFLE CUSHION FOUND DEFLATED TWELVE DAYS LATER. WAFFLE CUSHION TO ACCOMMODATE UP TO 300 LBS. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, BARIATRIC WAFFLE CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO CUSTOMER SERVICE TEAM LEAD. DEFLATED CUSHION TO BE PICKED UP BY EHOB REPRESENTATIVE. REPLACEMENT CUSHION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745621 200WC BARIATRIC WAFFLE CUSHION CUSHION, FLOTATION KIC EHOB INC REV00 332112D

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female