BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2803306 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00132
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    October 1, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L EXPIRATION DATE: 07/2011. ADD'L MANUFACTURE DATE: 07/2008. (B)(4). THE URGE INCONTINENCE CONTINUES. THE PHYSICIAN ASSESSED THAT THE URGE INCONTINENCE WAS MILD AND WAS DEFINITELY NOT RELATED TO THE DEVICE. THE PHYSICIAN ASSESSED THAT THE (B)(6) 2010 UTI WAS MILD AND WAS DEFINITELY NOT RELATED TO THE DEVICE. COAPTITE P/N (B)(4), LOT 1013204 EXP DATE 04/2012, DATE OF MANUFACTURE: 04/2009, INJECTED BY A HEALTH PROFESSIONAL. 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 (PJ) WAS ENROLLED IN (B)(6)STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2009 THE PT WAS INJECTED WITH 1.0ML OF COAPTITE - LOT 1012200. ON (B)(6) 2009 THE PT WAS INJECTED WITH 2.0ML OF COAPTITE - LOT 1010447, 1013204. ON (B)(6) 2009 THE PT REPORTED THAT SHE HAD URGE INCONTINENCE. THE PT WAS GIVEN SAMPLES OF TOPICAL ANTICHOLINERGIC MEDICATION. ON (B)(6) 2010 THE PT HAD A URINARY TRACT INFECTION (UTI). THE PT GOT AN ANTIBIOTIC FROM HER PRIMARY CARE OFFICE ON (B)(6) 2010. ON (B)(6) 2010 THE UTI WAS RESOLVED. ON (B)(6) 2011 THE PT HAD A URINARY TRACT INFECTION (UTI). THE PT REC'D ANTIBIOTIC FROM AN URGENT CARE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1012200 / 1010447

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention