BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR HEAD 28 X 46 MM

    MDR report key: 4619996 · Received March 18, 2015

    Report

    Report Number
    3005180920-2015-00041
    Event Type
    Injury
    Date Received
    March 18, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K091967
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MARCH 2015: LOT 130774: 39 BIPOLAR HEADS MANUFACTURED AND RELEASED ON 29 MAY 2013. EXPIRATION DATE: 2018-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. ON 16 MARCH 2015 WE WERE INFORMED THAT NO ITEM WILL BE RECEIVED BACK.

    Description of Event or Problem · 1

    IMP REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185185 BIPOLAR HEAD 28 X 46 MM BIPOLAR HEAD, MEH, LZO MEH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1