BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARD HOODED CRIB WITH PORTLAND GATES

    MDR report key: 24687295 · Received March 25, 2026

    Report

    Report Number
    MW5185792
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 11, 2026
    Report Date
    March 18, 2026
    Manufacturer
    HARD MFG. CO., INC.
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PORTLAND GATE FELL OFF HOODED CRIB, RESULTING IN IMMEDIATE PATIENT FALL. FEW SECUREMENT PIECES WERE FOUND ON THE FLOOR, INDICATING PIECES WERE MISSING. HOODED CRIB IS MANUFACTURED BY HARD MODEL: E843-CGP SERIAL: (B)(6) TAG: 215278.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749904 HARD HOODED CRIB WITH PORTLAND GATES BED, PEDIATRIC OPEN HOSPITAL FMS HARD MFG. CO., INC. E843-CGP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other