BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULES HOSPITAL BED

    MDR report key: 17635370 · Received August 25, 2023

    Report

    Report Number
    MW5145008
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    August 23, 2023
    Report Date
    August 25, 2023
    Manufacturer
    THE MOREL COMPANY
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER STATED THAT SHE WAS IN THE HOSPITAL FOR ONE WEEK. DURING HER STAY, HER HOSPITAL BED WAS BEING USED AS A BETA-TESTER BED. REPORTER SAID THAT THE CLIPS THAT HOLD THE SHEET SECURELY ONTO THE BED WERE NOT WORKING WHICH EXPOSED HER TO THE MATTRESS WHICH IS MADE WITH A RUBBER OR SILICONE-LIKE MATERIAL. REPORTER STATED THAT SHE HAD AN "ANAPHYLAXIS" REACTION TO THE MATTRESS WHICH NEARLY KILLED HER. REPORTER STATES THAT THE BED IS A DEFECTIVE PRODUCT DUE TO THE SHEETS NOT STAYING ON HENCE, EXPOSING PATIENTS TO THE MATTRESS WHICH CAN BE HARMFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000126 HERCULES HOSPITAL BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL THE MOREL COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Life Threatening