BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1890853 · Received October 29, 2010

    Report

    Report Number
    2135225-2010-00065
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    May 18, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MERZ AESTHETICS, INC (FORMERLY BIOFORM MEDICAL, 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

    (B)(4). THIS EVENT WAS REPORTED IN THE LINE LISTING FOR THE (B)(4) STUDY STATUS REPORT FOR (B)(4), SUBMITTED TO THE FDA ON 9/30/2010. SINCE THE ADVERSE EVENT REQUIRED ANTIBIOTICS TO CORRECT THE UTI, THIS EVENT WAS DETERMINED TO BE A REPORTABLE EVENT. THE DEVICE HISTORY RECORDS FOR COAPTITE LOT 1011659 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    (B)(4) STUDY. A PT (B)(6), WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED WITH 2.0ML COAPTITE ON (B)(6) 2009. THE PT DEVELOPED A MILD URINARY TRACT INFECTION ON (B)(6) 2010 ((B)(6) MONTHS POST INJECTION). THE UTI WAS TREATED WITH ANTIBIOTICS FROM THE PT'S PRIMARY CARE PHYSICIAN, WHICH RESOLVED ON (B)(6) 2010. HOWEVER, AT THE RESOLUTION OF THE UTI, THE PT BEGAN EXPERIENCING URGE INCONTINENCE. THE PT WAS TREATED WITH INTRAVESICAL BOTOX INJECTIONS ON (B)(6) 2009, FOR THE URGE INCONTINENCE. DR (B)(6) DOES NOT FEEL THAT EITHER ADVERSE EVENT WAS RELATED TO THE COAPTITE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC (FORMERLY BIOFORM MEDICAL, INC.) 1011659

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention