BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE REFLECTIVE MARKER SPHERES

    MDR report key: 5015615 · Received August 19, 2015

    Report

    Report Number
    3002743211-2015-00048
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Report Date
    July 22, 2015
    Manufacturer
    NORTHERN DIGITAL INC.
    Product Code
    HAW
    PMA / PMN Number
    K100038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER (OR MANAGER, (B)(6)) INFORMED US THAT THEY HAD ONE ISSUE OF A SPHERE FALLING APART WHILE ATTEMPTING TO THREAD IT ONTO A POST. CUSTOMER CANNOT RECALL WHEN THE INCIDENT OCCURED, DID NOT RECORD LOT NUMBER OR ANY OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548291 DISPOSABLE REFLECTIVE MARKER SPHERES REFLECTIVE PASSIVE MARKER SPHERES HAW NORTHERN DIGITAL INC. 41773

    Patients

    Seq Age Sex Outcome Treatment
    1