BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    200WC BARIATRIC WAFFLE CUSHION

    MDR report key: 19536320 · Received June 14, 2024

    Report

    Report Number
    19536320
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    April 22, 2024
    Report Date
    April 26, 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 WAS ADMITTED TO ACUTE CARE ON [DATE REDACTED]. WAFFLE CUSHION INITIATED 2 DAYS LATER [DATE REDACTED]. PATIENT WAS DISCHARGED TO SNF FOLLOWING DAY [DATE REDACTED]. PATIENT WEIGHED [WEIGHT REDACTED]. WAFFLE CUSHION FOUND DEFLATED 11 DAYS LATER [DATE REDACTED]. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, WAFFLE CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO [E-MAIL REDACTED] ON [DATE REDACTED] WITH IMMEDIATE RESPONSE CONCERNING REPLACEMENT CUSHIONS AND RETURN OF EQUIPMENT TO MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168782 200WC BARIATRIC WAFFLE CUSHION CUSHION, FLOTATION KIC EHOB, INC. 404512D

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female