BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1890905 · Received October 29, 2010

    Report

    Report Number
    2135225-2010-00078
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    March 25, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MERZ AESTHETICS, INC (FORMALLY BIOFORM MEDICAL, INC)
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT WAS REPORTED IN THE LINE LISTING OF 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 1012833 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 PATIENT (B)(6) WAS ENROLLED IN THE (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH 3.0 ML COAPTITE ON (B)(6) 2010. THE PATIENT DEVELOPED A MODERATE URINARY TRACT INFECTION APPROXIMATELY (B)(6) 2010, WAS TREATED WITH ANTIBIOTICS AND THE SYMPTOMS RESOLVED ABOUT (B)(6) 2010. THE AE WAS REPORTED BY THE PATIENT'S DAUGHTER, TO DR. (B)(6). THE DAUGHTER DID NOT REMEMBER EXACT DATE OR TYPE OF ANTIBIOTICS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC (FORMALLY BIOFORM MEDICAL, INC) 1012833

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention