BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 1890897 · Received October 29, 2010

    Report

    Report Number
    2135225-2010-00070
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    February 10, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.)
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT: 1015021, EXPIRATION DATE: 09/30/2012. ADD'L MANUFACTURE DATE: 09/2009. (B)(4). THIS EVENT WAS REPORTED IN THE LINE LISTING OF THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR (B)(4), SUBMITTED TO THE FDA ON 09/30/2010. SINCE THE ADVERSE EVENT REQUIRED CATHETERIZATION TO CORRECT URINARY RETENTION, THIS EVENT WAS DETERMINED TO BE A REPORTABLE EVENT. THE DEVICE HISTORY RECORDS FOR COAPTITE LOTS 1012109 AND 1015021 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED FOR EITHER LOT.

    Description of Event or Problem · 1

    COAPTITE POST APPROVAL STUDY. A PT (B)(6), WAS ENROLLED IN THE POST-APPROVAL COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED TWICE; ON (B)(6) 2009 WITH 2.0 ML COAPTITE AND AGAIN ON (B)(6) 2010 WITH 1.5 ML OF COAPTITE. THE PT NOTES INDICATE THAT AFTER THE SECOND COAPTITE INJECTION ON (B)(6) 2010, THE PT WAS UNABLE TO VOID. THE PT WAS CATHETERIZED WITH A FOLEY CATHETER FOR 2 DAYS. ON (B)(6) 2010, THE PT WAS ABLE TO SPONTANEOUSLY VOID AFTER THE CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.) 1012109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention