BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6902243 · Received September 28, 2017

    Report

    Report Number
    1836161-2017-00098
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    June 26, 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, PICTURE PROVIDED.

    Description of Event or Problem · 1

    DEFECTIVE PRODUCT OF ITEM NB8000. COMPLAINT DESCRIPTION IS SPLIT IN HANDLE OF LIGHT HANDLE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681127 MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILE LIGHT SHIELD FTA ASPEN SURGICAL PRODUCTS, CALEDONIA NB8000 119366

    Patients

    Seq Age Sex Outcome Treatment
    1