BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAPT SYSTEMS, INC.

    MDR report key: 2004036 · Received February 23, 2011

    Report

    Report Number
    2020601-2011-00002
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    December 10, 2010
    Report Date
    February 21, 2011
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO SECOND PROCEDURE REQUIRED IN ORDER TO REMOVE ENCAPSULATION/IMPLANT, IT WAS DETERMINED THAT EVENT WAS REPORTABLE TO F.D.A.

    Description of Event or Problem · 1

    RECEIVED REPORT FROM CUSTOMER INDICATING THAT ENCAPSULATION HAD OCCURRED FROM AN IMPLANT WHICH WAS ORIGINALLY INSTALLED ON (B)(6) 2010. THE ENCAPSULATION REQUIRED A SECOND SURGERY TO BE PERFORMED ON (B)(6) 2010 TO REMOVE THE ENCAPSULATED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPT SYSTEMS, INC. ULTRATINE (FIXATION DEVICE) HWC COAPT SYSTEMS, INC. 23202 2715 (QTY. 1)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention