BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 3429664 · Received October 17, 2013

    Report

    Report Number
    2135225-2013-00134
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    November 30, 2012
    Report Date
    September 20, 2013
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOTS USED: 1018987 (EXPIRATION DATE 05/2013, MANUFACTURED ON 05/2010) AND 1020122 (EXPIRATION DATE 07/2013, MANUFACTURED ON 07/2010). THE DEVICE HISTORY RECORDS FOR ALL THREE LOTS WERE REVIEWED, ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT ((B)(6)) WAS ENROLLED IN THE POST-APPROVAL COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2010, THE PT WAS INJECTED WITH 2.0 ML COAPTITE, LOT 1018987. ON (B)(6) 2010, THE PT WAS ALSO INJECTED WITH 2.0 ML COAPTITE, LOT 1018987. ON (B)(6) 2011, THE PT WAS ALSO INJECTED WITH 2.0 ML COAPTITE, LOT 1020122. ON (B)(6) 2012, THE PT DEVELOPED URINARY TRACT INFECTION. THE PT WAS TREATED WITH MACROBID STARTING ON (B)(6) 2012; DOSE, FREQUENCY AND DURATION WERE NOT REPORTED. THE ADVERSE EVENT RESOLVED ON (B)(6) 2012. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533487 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC 1018987

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention