BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACOBSON MICRO MOSQ 5 CV

    MDR report key: 4380111 · Received December 24, 2014

    Report

    Report Number
    2523190-2014-00073
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Report Date
    December 4, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EKD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THE TIP BROKE IN PT ON FIRST USE FROM PACKAGE. ON (B)(6) 2014 CUSTOMER REPORTS DOCTOR WAS PERFORMING A THYROIDECTOMY WHEN HE MANIPULATED THE TIP OF THE DEVICE UNDER A BLOOD VESSEL AND IT BROKE OFF. TIP EASILY RETRIEVED, NO HARM DONE. DOCTOR FELT NO NEED FOR X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851581 JACOBSON MICRO MOSQ 5 CV M6 - NEURO EKD INTEGRA YORK, PA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR