BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 4223984 · Received October 29, 2014

    Report

    Report Number
    2135225-2014-00069
    Event Type
    Other
    Date Received
    October 29, 2014
    Date of Event
    August 2, 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: 1036243, EXPIRATION DATE 10/2015, MANUFACTURED 10/2012. THE DEVICE HISTORY RECORDS FOR THE 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) 2012, THE PT WAS INJECTED WITH 2.0 ML COAPTITE, LOT 1032764. ON THE SAME DAY, THE PT DEVELOPED URETHRAL SWELLING AS A RESULT OF THE COAPTITE INJECTION, DIAGNOSED BY BLADDER ULTRASOUND. THE PT WAS TREATED WITH STRAIGHT CATHETERIZATION ADN FOLEY CATHETERIZATION AND RECOVERED. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND DEFINITELY RELATED TO COAPTITE. ON (B)(6) 2013, THE PT WAS INJECTED WITH 1.0 ML COAPTITE, LOT 1036243. ON (B)(6) 2012, THE PT DEVELOPED URINARY TRACT INFECTION DIAGNOSED BY URINE CULTURE. THE PT WAS TREATED WITH AN ANTIBIOTIC TREATMENT AND RECOVERED. 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
    692800 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1032764

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention