BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2803304 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00135
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    November 12, 2010
    Report Date
    September 17, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L EXPIRATION DATE: 05/2013. ADD'L IMPLANT DATE: (B)(6) 2010. ADD'L MANUFACTURE: 05/2010. (B)(4). THE PHYSICIAN ASSESSED THE RETENTION AS MILD AND DEFINITELY RELATED TO THE DEVICE. THE PHYSICIAN ASSESSED THE URGE INCONTINENCE AS MILD AND DEFINITELY NOT RELATED TO THE DEVICE. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBERS WERE REVIEWED, ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT (B)(6), WAS ENROLLED IN (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2010, THE PT WAS INJECTED WITH 2.0ML OF COAPTITE. ON (B)(6) 2010, THE PT HAD URINARY RETENTION THAT WAS CONFIRMED BY A BLADDER SCAN. THE PT HAD A FOLEY CATHETER PLACED ON (B)(6) 2010. THE RETENTION WAS RESOLVED ON (B)(6) 2010. ON (B)(6) 2010 THE PT WAS INJECTED WITH 2.0ML OF COAPTITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1018597 / 1018987

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention