BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 5189977 · Received October 29, 2015

    Report

    Report Number
    2135225-2015-00091
    Event Type
    Injury
    Date Received
    October 29, 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. DEVICE NOT RETURNED TO THE MANUFACTURER.

    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
    720368 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1034173

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention