BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334550 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00126
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    July 29, 2010
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED IN THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR PMA P040047, 09/16/2011. AT THE TIME OF THIS REPORT, THE SYMPTOMS HAD RESOLVED. THE DEVICE HISTORY RECORDS FOR COAPTITE LOTS 1016946 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PATIENT (B)(6), WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED ON (B)(6) 2010, WITH 1.0ML OF COAPTITE (LOT 1016946). THE PATIENT REQUIRED FOLEY CATHETER PLACEMENT PRIOR TO LEAVING THE OFFICE, AFTER THE COAPTITE INJECTION PROCEDURE. THE CATHETER REMAINED IN PLACE UNTIL (B)(6) 2010. THE PHYSICIAN RECORDED THE INFORMATION IN THE 1 MONTH POST AE FORM; INDICATING THE AE SEVERITY WAS MILD. THE PATIENT ALSO DEVELOPED A URINARY TRACT INFECTION ON (B)(6) 2010, AND WAS TREATED WITH ANTIBIOTICS FOR 10 DAYS. THE UTI WAS MEDICALLY ASSESSED AS POSSIBLY RELATED TO THE COAPTITE INJECTION, AND OF MILD SEVERITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1016946

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention