BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINANT LOCALIZER

    MDR report key: 3994725 · Received June 11, 2014

    Report

    Report Number
    1222895-2014-00010
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Report Date
    April 16, 2014
    Manufacturer
    INTEGRA BURLINGTON MA INC
    Product Code
    HAW
    PMA / PMN Number
    K946252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AN LL01 (LUMINANT LOCALIZER) WAS BROKEN. IT WAS THEN DETERMINED THAT THE PLASTIC AT THE BASE OF THE UNIT WAS BROKEN AND THE ISSUE WAS FOUND DURING PRE OP. IT WAS NOT CONFIRMED THAT THE PATIENT HAD THE UNIT IN PLACE WHEN THE ISSUE WAS FOUND. ADDITIONAL INFO RECEIVED ON (B)(4) 2014. THIS COMPLAINT CHANGED TO AN MDR. THEN ON (B)(6) 2014, THE CUSTOMER CONFIRMED THAT THE LL01 WAS PLACED ON THE PATIENT PRIOR TO THE PROCEDURE. THE PROCEDURE WAS DELAYED; HOWEVER, IT IS UNK HOW LONG IT WAS DELAYED. THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344552 LUMINANT LOCALIZER NA HAW INTEGRA BURLINGTON MA INC

    Patients

    Seq Age Sex Outcome Treatment
    1