BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOU MAJOR PROCEDURE LIGHT HANDLE COVERS

    MDR report key: 8703736 · Received June 14, 2019

    Report

    Report Number
    MW5087390
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    June 6, 2019
    Report Date
    June 12, 2019
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FTA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OPENED A MAJOR PACK FROM MEDLINE AND THE LIGHT COVER HANDLES HAD SLITS IN THEM. OPENED AN INDIVIDUAL LIGHT HANDLE AND IT HAD A PIN HOLE IN IT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495594 LOU MAJOR PROCEDURE LIGHT HANDLE COVERS LIGHT, SURGICAL ACCESSORIES FTA MEDLINE INDUSTRIES, INC. 19DBD799

    Patients

    Seq Age Sex Outcome Treatment
    1