BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334452 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00140
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    June 10, 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
    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. THE PHYSICIAN DETERMINED THAT THE URINARY RETENTION WAS MODERATE AND WAS DEFINITELY RELATED TO THE COAPTITE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER 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 HAS HAD ONE PRIOR SURGERY FOR INCONTINENCE. ON (B)(6) 2010 THE PT WAS INJECTED FOR 2 ML OF COAPTITE. ON (B)(6) 2010 THE PT REPORTED URINARY RETENTION AND A FOLEY CATHETER WAS PLACED. THE URINARY RETENTION WAS RESOLVED ON (B)(6) 2010. ON (B)(6) 2010 THE PT RETURNED AFTER BEING UNABLE TO VOID FOR 6 HOURS AND THE FOLEY CATHETER WAS REPLACED. THE URINARY RETENTION WAS RESOLVED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS INC 1017141

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention