BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334462 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00146
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    June 10, 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
    OH, 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. AT THE TIME OF THIS REPORT, THE SYMPTOMS HAD RESOLVED. THE DEVICE HISTORY RECORDS FOR COAPTITE LOT 1016640 WERE 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 WAS INJECTED ON (B)(6) 2010 WITH 2.0 ML OF COAPTITE (LOT 1016640 X2). THE PT DEVELOPED MODERATE URINARY RETENTION (SAME DAY AS PROCEDURE) AND WAS TREATED WITH FOLEY CATHETER. THE CATHETER WAS REMOVED ON (B)(6) 2010 WITH FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC 1016640

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention