BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 4223974 · Received October 29, 2014

    Report

    Report Number
    2135225-2014-00070
    Event Type
    Other
    Date Received
    October 29, 2014
    Date of Event
    December 12, 2012
    Report Date
    October 1, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT INJECTED ON (B)(6) 2011: 1020842 (EXPIRATION DATE 08/2013, MANUFACTURED 08/2010). THE DEVICE HISTORY RECORDS FOR TWO REPORTED 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 (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2010, THE PT WAS INJECTED WITH 1.0 ML COAPTITE, LOT 1018596; AND ON (B)(6) 2014, THE PT WAS INJECTED WITH A 1.0 ML COAPTITE, LOT 1020842. ON (B)(6) 2012, THE PT DEVELOPED URINARY TRACT INFECTION AS REPORTED BY THE PT. THE PT WAS TREATED WITH ANTIBIOTICS FROM THE PRIMARY CARE PHYSICIAN. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE. THE PT RECOVERED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692791 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1018596

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention