BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 5172167 · Received October 24, 2015

    Report

    Report Number
    2135225-2015-00079
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    March 21, 2013
    Report Date
    September 25, 2015
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE. THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PATIENT ((B)(6)) WAS ENROLLED IN THE POST-APPROVAL COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH A TOTAL OF 3.0ML OF COAPTITE, LOTS 1033386, 1032766, 1032765 ON (B)(6) 2012. ON (B)(6) 2013 A URINE CULTURE WAS PERFORMED AND THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION. THE PATIENT WAS TREATED WITH KEFLEX 500MG BID X 7 DAYS STARTING ON (B)(6) 2013. AS OF (B)(6) 2013 THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND POSSIBLY DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703724 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1033386

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention