BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334571 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00134
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    March 7, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT WAS REPORTED IN THE (B)(4) STUDY STATUS REPORT FOR PMA P040047, 9/16/2011. THE PHYSICIAN DETERMINED THAT THE URINARY RETENTION WAS MILD AND WAS DEFINITELY RELATED TO THE COAPTITE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS 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 HAS HAD ONE PREVIOUS COAPTITE TREATMENT. THE PT HAS HAD ONE PRIOR SURGERY FOR INCONTINENCE. ON (B)(6) 2011, THE PT WAS INJECTED WITH 2.0ML OF COAPTITE. ON (B)(6) 2011, THE PHYSICIAN OBSERVED THAT THE PT HAD URINARY RETENTION AND A FOLEY CATHETER WAS PLACED. ON (B)(6) 2011, THE URINARY RETENTION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1022101

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention