BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334554 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00131
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    November 3, 2010
    Report Date
    October 7, 2011
    Manufacturer
    MERZ AESTHETICS, 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

    ADDITIONAL INFO FOR SECTIONS: CATALOG# 8005P10, LOT# 1019527, EXPIRATION DATE: 06/2013. IMPLANT DATE: (B)(6) 2010. MANUFACTURE DATE: 06/2010. THIS EVENT WAS REPORTED IN THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR PMA P040047, (B)(6) 2011. AT THE TIME OF THIS REPORT, THE SYMPTOMS HAD RESOLVED. THE DEVICE HISTORY RECORDS FOR COAPTITE LOTS 1018439 AND 1019527 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PT (B)(6) WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED ON (B)(6) 2010 WITH 2.0ML OF COAPTITE (LOTS 1018439 AND 1019527). THE PT REQUIRED FOLEY CATHETER PLACEMENT PRIOR TO LEAVING THE OFFICE, AFTER THE COAPTITE INJECTION PROCEDURE. THE CATHETER REMAINED IN PLACE UNTIL (B)(6) 2010; AE SEVERITY WAS MILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1018439

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention