BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334451 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00139
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    March 30, 2011
    Report Date
    October 7, 2011
    Manufacturer
    MERZ AESTHETICS 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

    THIS EVENT WAS REPORTED IN THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR PMA P040047, (B)(6) 2011. ADD'L LOT NUMBERS OF COAPTITE INJECTED INTO THE PT: 1016314 EXP DATE: 11/2012, MFR DATE: 11/2009, DATE INJECTED: (B)(6) 2010; 1015701 EXP DATE: 10/2012, MFR DATE: 1/2010, DATE INJECTED: (B)(6) 2010. THE PHYSICIAN DETERMINED THE UTI TO BE MILD AND THAT IT WAS PROBABLY NOT RELATED TO THE COAPTITE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBERS WAS REVIEWED; ALL REQUIRED TESTING SPECS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT (B)(6), WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PT HAS NOT HAD ANY PREVIOUS COAPTITE TREATMENTS. THE PT WAS INJECTED ON (B)(6) 2010 WITH 2.0 ML OF COAPTITE (LOT 1015701). ON (B)(6) 2010 THE PT WAS INJECTED WITH 2.0 ML OF COAPTITE (LOTS 1016314 AND 1015701). ON (B)(6) 2011 THE PT WAS DIAGNOSED WITH A URINARY TRACT INFECTION (UTI). THE PT WAS PRESCRIBED CIPRO 500 MG B.I.D. FOR 7 DAYS. ON (B)(6) 2011 THE UTI WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS INC 1015701

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention