BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 5190453 · Received October 30, 2015

    Report

    Report Number
    2135225-2015-00094
    Event Type
    Injury
    Date Received
    October 30, 2015
    Date of Event
    March 12, 2014
    Report Date
    September 29, 2015
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THIS MDR IS RELATED TO 2135225-2015-00091 & 2135225-2015-00093.

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2012 THE PATIENT WAS INJECTED WITH 3.0ML OF COAPTITE, LOTS 1032138 & 1031015. NO ADVERSE EVENT REPORTED. ON (B)(6) 2012 THE PATIENT WAS INJECTED WITH 4.0ML OF COAPTITE, LOTS 1034173, 1032763, 1032765. ON (B)(6) 2014 THE PATIENT REPORTED A URINARY TRACT INFECTION. ON (B)(6) 2014 THE PATIENT WAS PRESCRIBED ANTIBIOTIC TREATMENT BY HER PRIMARY CARE PHYSICIAN (NAME OF ANTIBIOTIC, DOSE & DURATION UNKNOWN). THE PHYSICIAN ASSESSED THE EVENT AS MILD AND DEFINITELY NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722370 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1032765

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention