BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1749440 · Received July 2, 2010

    Report

    Report Number
    2135225-2010-00044
    Event Type
    Other
    Date Received
    July 2, 2010
    Date of Event
    December 8, 2009
    Report Date
    March 24, 2010
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT 1012109, EXP DATE: 01/01/2012, INJECTION DATE (B)(6) 2009, DEVICE MFG DATE 01/2009. THIS EVENT WAS REPORTED IN THE LINE LISTING OF THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR (B)(4), SUBMITTED TO THE FDA IN MARCH 2010. SINCE THE ADVERSE EVENT REQUIRED ANTIBIOTICS, IT WAS DETERMINED TO BE REPORTABLE EVENT. THE DEVICE HISTORY RECORDS FOR COAPTITE LOT 1011464 AND 1012109 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED FOR EITHER LOT.

    Description of Event or Problem · 1

    COAPTITE POST APPROVAL STUDY. PT ((B)(6)) INJECTED WITH 3.0 ML OF COAPTITE INJECTABLE IMPLANT FOR STRESS URINARY INCONTINENCE ON (B)(6) 2009 AND A SECOND COAPTITE INJECTION OF 3.0 ML ON (B)(6) 2009. FIVE MONTHS AFTER THE SECOND COAPTITE INJECTION ((B)(6) 2009), THE PT DEVELOPED A URINARY TRACT INFECTION, WHICH WAS TREATED WITH ANTIBIOTICS (MACROBID 100 MG) FOR 5 DAYS AND NIGHTLY FOR 60 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM BIOFORM MEDICAL, INC. 1011464

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention