BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR

    MDR report key: 7017848 · Received November 10, 2017

    Report

    Report Number
    9614209-2017-00073
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    September 19, 2017
    Report Date
    November 10, 2017
    Manufacturer
    CORIN MEDICAL
    Product Code
    KWY
    PMA / PMN Number
    K925897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADVERSE EVENT HAS BEEN REPORTED. THE EVENT REPORTED TO CORIN, THAT "THE HEAD OF A PRE ASSEMBLED BIPOLAR PROSTHESIS CAME OUT" IS IDENTIFIABLE AND AN ALTERNATIVE DEVICE COULD BE USED. HOWEVER, THE EVENT REPORT SUBMITTED TO CORIN ALSO MENTIONS A DEVICE REVISION, IT IS UNKNOWN AT THIS TIME WHETHER OR NOT THE DEVICES BEING REVISED WERE CORIN PRODUCTS. THIS INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THIS INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED, THIS DEVICE CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    THE HEAD CAME AWAY FROM A PRE ASSEMBLED CORIN BIPOLAR PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796273 BIPOLAR CORIN BIPOLAR PROSTHESIS KWY CORIN MEDICAL J111.252 344547

    Patients

    Seq Age Sex Outcome Treatment
    1