BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 2334570 · Received November 4, 2011

    Report

    Report Number
    2135225-2011-00133
    Event Type
    Other
    Date Received
    November 4, 2011
    Date of Event
    April 14, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: CATALOG# 8005P10, LOT# 1012109, EXPIRATION DATE: 01/2012. IMPLANT DATE: (B)(6) 2009. MANUFACTURE DATE: 01/2009. CATALOG# 8005P10, LOT# 1015912, EXPIRATION DATE: 11/2012. IMPLANT DATE: (B)(6) 2010. MANUFACTURE DATE: 11/2009. CATALOG# 8005P10, LOT# 1017758, EXPIRATION DATE: 03/2013. IMPLANT DATE: (B)(6) 2010. MANUFACTURE DATE: 03/2010. THIS EVENT WAS REPORTED IN THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR PMA P040047, (B)(4) 2011. AT THE TIME OF THIS REPORT, THE SYMPTOMS HAD RESOLVED. THE DEVICE HISTORY RECORDS FOR COAPTITE LOTS 1010152 AND 1012109, 1015912, AND 1017758 REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED. THE COAPTITE LOTS FROM THE (B)(6) 2008, WERE NOT RECORDED.

    Description of Event or Problem · 1

    A PT (B)(6) WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED WITH COAPTITE SEVERAL TIMES BETWEEN (B)(6) 2008 AND (B)(6) 2010: (B)(6) 2008, WITH 1.7ML (NO LOT IDENTIFIED), (B)(6) 2008, WITH 1.0ML (NO LOT IDENTIFIED), (B)(6) 2009, WITH 0.8ML (LOT 1010152), (B)(6) 2009, WITH 2.0ML (LOT 1012109 X2), (B)(6) 2010, WITH 1.0ML (LOT 1015912), (B)(6) 2010, WITH 1.0ML (LOT 101775X). AFTER THE FIFTH COAPTITE INJECTION ((B)(6) 2010), THE PT DEVELOPED SEVEN SEPARATE URINARY TRACT INFECTIONS. THE FIRST WAS IDENTIFIED ON (B)(6) 2010 AND TREATED WITH ANTIBIOTICS UNTIL (B)(6) 2010. THE SECOND ON (B)(6) 2010 UNTIL (B)(6) 2010, THE THIRD FROM (B)(6) 2010, UNTIL (B)(6) 2010, THE FOURTH FROM (B)(6) 2010 UNTIL (B)(6) 2010, THE FIFTH FROM (B)(6) 2010 UNTIL (B)(6) 2010, THE SIXTH FROM (B)(6) 2010 UNTIL (B)(6) 2010 AND THE SEVENTH FROM (B)(6) 2010 UNTIL (B)(6) 2010. ALL WERE TREATED WITH ANTIBIOTICS AND WERE OF MILD SEVERITY. THE PHYSICIAN FELT EACH OF THESE UTIS WERE PROBABLY NOT RELATED TO THE AE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1010152

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention