BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2803326 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00142
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    March 3, 2011
    Report Date
    September 17, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L EXPIRATION DATE: 04/2012. ADD'L IMPLANTED DATE: (B)(6) 2010. ADD'L MANUFACTURE DATE: 04/2009. (B)(4). THE PHYSICIAN ASSESSED THE UTI AS MILD AND PROBABLY NOT RELATED TO THE DEVICE. THE PHYSICIAN ASSESSED THE BREAST CANCER AS IS MODERATE AND DEFINITELY NOT RELATED TO THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOTS MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A PT (LS) WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2009 THE PT WAS INJECTED WITH 1.0ML ON (B)(6) 2009, LOT 1011521. ON (B)(6) 2010, AT THE 12 MONTH F/U THE PT WAS INJECTED WITH 2.0ML, LOTS 1011521 AND 1013180. ON (B)(6) 2011 THE PT HAD A URINARY TRACT INFECTION (UTI). THE PT COMPLAINED OF ABDOMINAL DISCOMFORT. THE PT WAS TREATED WITH 250MG PO B.I.D. X 5 DAYS AND RECOVERED ON (B)(6) 2011. ON (B)(6) 2012 THE PT WAS DIAGNOSED WITH BREAST CANCER. ON (B)(6) 2012 THE PT HAD SURGERY AND RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1011521 / 1013180

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention