BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILE

    MDR report key: 6957357 · Received October 18, 2017

    Report

    Report Number
    1836161-2017-00111
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 18, 2017
    Report Date
    October 18, 2017
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FTA
    PMA / PMN Number
    K020304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MULTIPLE INSTANCES OF CRACKED LIGHT SHIELDS ITEM NB8001 LOT 141757. THE CRACKS ARE IN THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738083 MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILE LIGHT SHIELD FTA ASPEN SURGICAL PRODUCTS, CALEDONIA NB8001 141757

    Patients

    Seq Age Sex Outcome Treatment
    1