BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1749449 · Received July 2, 2010

    Report

    Report Number
    2135225-2010-00042
    Event Type
    Other
    Date Received
    July 2, 2010
    Date of Event
    March 23, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 LOT 1010448 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED FOR THIS 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. FROM THE DATE OF INJECTION, THE PT WAS TREATED WITH INTERMITTENT CATHETERIZATION. TWO DAYS POST INJECTION, THE PT RETURNED TO THE CLINIC TO HAVE HER BLADDER DRAINED ON (B)(6) 2009. A FOLEY CATHETER WAS INSERTED ON (B)(6) 2009 WITH INSTRUCTIONS (TO THE PT) FOR THE CATHETER TO REMAIN IN PLACE UNTIL (B)(6) 2009. THE PT REQUESTED TO BE HOSPITALIZED ON (B)(6) 2009; NOT DETERMINED TO BE MEDICALLY NECESSARY PER TREATING PHYSICIAN. THE PT DEVELOPED A URINARY TRACT INFECTION ON (B)(6) 2009, DIAGNOSED DURING URINE CULTURE, AND TREATED WITH ANTIBIOTICS FOR 15 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM BIOFORM MEDICAL, INC. 1010448

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention