BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAPT SYSTEMS, INC.

    MDR report key: 2309128 · Received October 20, 2011

    Report

    Report Number
    2020601-2011-00004
    Event Type
    Injury
    Date Received
    October 20, 2011
    Date of Event
    September 6, 2011
    Report Date
    October 13, 2011
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K032770
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO SECOND PROCEDURE REQUIRED IN ORDER TO REPLACE INITIAL IMPLANT, IT WAS DETERMINED THAT EVENT WAS REPORTABLE TO THE F.D.A.

    Description of Event or Problem · 1

    RECEIVED REPORT FROM CUSTOMER INDICATING THAT THE ITEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2011. UPON POST OPERATION APPOINTMENT OF (B)(6) 2011, A SECOND SURGERY WAS PERFORMED, AS ONE OF THE IMPLANTS FROM THE FIRST SURGERY HAD NOT STAYED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPT SYSTEMS, INC. ENDOTINE (FIXATION DEVICE) HWC COAPT SYSTEMS, INC. 22202 2886 (QTY. 1)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention