BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE REFLECTIVE MARKER SPHERES

    MDR report key: 4888646 · Received July 2, 2015

    Report

    Report Number
    3002743211-2015-00038
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 8, 2015
    Manufacturer
    NORTHERN DIGITAL INC.
    Product Code
    HAW
    PMA / PMN Number
    K100038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS COMMUNICATED BY (B)(6) FROM (B)(6) HOSPITAL IN RESPONSE TO A RECALL NOTICE ISSUED FOR THE SAME MODEL OF SPHERES. AS NOTED BY THE COMPLAINANT, DURING A PROCEDURE SPHERES BROKE APART. THERE WAS NO REPORT OF ANY PATIENT/USER INJURY, DEATH OR SERIOUS DETERIORATION IN HEALTH. COMPLAINANT DISPOSED OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431367 DISPOSABLE REFLECTIVE MARKER SPHERES REFLECTIVE PASSIVE MARKER SPHERES HAW NORTHERN DIGITAL INC. 41773

    Patients

    Seq Age Sex Outcome Treatment
    1