BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1749445 · Received July 2, 2010

    Report

    Report Number
    2135225-2010-00039
    Event Type
    Other
    Date Received
    July 2, 2010
    Date of Event
    April 4, 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 1010736, EXP DATE: 09/01/2011. DEVICE MFG DATE: 09/2008. 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 CATHETERIZATION, IT WAS DETERMINED TO BE A REPORTABLE EVENT. THE DEVICE HISTORY RECORDS FOR COAPTITE LOTS 1010558 AND 1010736 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATION 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 INJECTED WITH 2.0ML OF COAPTITE INJECTABLE IMPLANT FOR STRESS URINARY INCONTINENCE ON (B)(6) 2009. TWO DAYS POST INJECTION ((B)(6) 2009), THE PT DEVELOPED URINARY RETENTION WHICH WAS DETECTED WITH A BLADDER ULTRASOUND. THE PT WAS TREATED WITH STRAIGHT CATHETERIZATION AND A FOLEY CATHETER FOR TWO WEEKS; THE RETENTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM BIOFORM MEDICAL, INC. 1010558

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention