BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARD

    MDR report key: 213028 · Received March 4, 1999

    Report

    Report Number
    MW1015824
    Event Type
    Malfunction
    Date Received
    March 4, 1999
    Date of Event
    January 14, 1999
    Report Date
    January 19, 1999
    Manufacturer
    HARD MFG CO, INC.
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE MFR ON 04/05/1999: ON 01/14/1999, THE FACILITY CONTACTED THE MFR AND INFORMED THE CO OF A HITCH PIN MISSING FROM THE VINYL TOP COVER. THE FACILITY STATED THE VINYL COVER FELL INTO THE CRIB, AND THE PT WAS NOT INJURED. CO'S PARTS DEPARTMENT OVER-NIGHTED THE HITCH CLIP PIN TO THE FACILITY, AND THE MAINTENANCE DEPARTMENT REPLACED THE PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARD INFANT CRIB FMS HARD MFG CO, INC. 1943 SPRINGFIELD CRIB *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other