BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6901979 · Received September 28, 2017

    Report

    Report Number
    1836161-2017-00107
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    April 25, 2017
    Report Date
    September 28, 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

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    (B)(4) ON ITEM NB8000. CRACKED LIGHT SHIELDS IN KITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682148 MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILE LIGHT SHIELD FTA ASPEN SURGICAL PRODUCTS, CALEDONIA NB8000 114900

    Patients

    Seq Age Sex Outcome Treatment
    1