BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1749431 · Received July 2, 2010

    Report

    Report Number
    2135225-2010-00033
    Event Type
    Other
    Date Received
    July 2, 2010
    Date of Event
    February 24, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT 1009317, EXP DATE: 04/01/2011, INJECTION DATES: (B)(6) 2008, (B)(6) 2009. DEVICE MFG DATE: 04/2008. 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 A REPORTABLE EVENT. THE DEVICE HISTORY RECORDS FOR COAPTITE LOTS 1009279 AND 1009317 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED FOR EITHER LOT. THE COAPTITE LOT NUMBER FROM THE FIRST INJECTION ((B)(6) 2008) HAD NOT BEEN PROVIDED; QUERY FOR MOST PROBABLY LOT USED WILL BE CONDUCTED BY THE U.S.A. COAPTITE DISTRIBUTOR, BOSTON SCIENTIFIC CORP.

    Description of Event or Problem · 1

    COAPTITE POST APPROVAL STUDY. PT INJECTED WITH COAPTITE INJECTABLE IMPLANT FOR STRESS URINARY INCONTINENCE ON THREE SEPARATE OCCASIONS. THE FIRST OF 2.0ML COAPTITE WAS ON (B)(6) 2008, THE SECOND OF 2.0ML COAPTITE ON (B)(6) 2008, AND THE THIRD OF 3.0ML COAPTITE ON (B)(6)2009. THE PT DEVELOPED A URINARY TRACT INFECTION, ONCE WEEK AFTER THE THIRD INJECTION. THE PT WAS TREATED WITH ANTIBIOTICS FOR ONE WEEK AND THE UTI RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM BIOFORM MEDICAL, INC. 1009279

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention