BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334566 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00128
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    August 23, 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 (B)(4) STUDY STATUS REPORT FOR PMA P040047, (B)(6) 2011. AT THE TIME OF THIS REPORT, THE SYMPTOMS HAD RESOLVED. THE DEVICE HISTORY RECORDS FOR COAPTITE LOT (B)(4) 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 PT (B)(6) WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED ON (B)(6) 2010, WITH 2.0ML OF COAPTITE (LOT (B)(4)). THE PT DEVELOPED A URINARY TRACT INFECTION, WHICH WAS DISCOVERED DURING URINALYSIS AND THE PT'S REPORT ON (B)(6) 2010. THE UTI WAS TREATED FOR ANTIBIOTICS; RESOLVED ON (B)(6) 2010. THE PHYSICIAN INDICATED THIS WAS OF MILD SEVERITY AND WAS PROBABLY NOT RELATED TO THE COAPTITE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1018439

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention