BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 2803357 · Received October 17, 2012

    Report

    Report Number
    2135225-2012-00123
    Event Type
    Other
    Date Received
    October 17, 2012
    Date of Event
    March 1, 2011
    Report Date
    September 17, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COAPTITE LOT #1014325, EXP 07/2012, MFG DATE 07/2009. COAPTITE LOT #1014688, EXP 08/2012, MFG DATE 08/2009. COAPTITE LOT #1024083, EXP 02/2014, MFG DATE 02/2011. AT THE TIME OF THIS REPORT THE PATIENT'S URINARY TRACT INFECTION HAD RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOTS #1014325, 1014688, 1015022 AND 1024083 MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A PATIENT (B)(6) WAS ENROLLED IN THE (B)(6) FOR STRESS URINARY INCONTINENCE. THE PATIENT WAS INJECTED WITH 2.0 ML OF COAPTITE LOTS #1014688 ON (B)(6) 2009. THE PATIENT RECEIVED A SECOND INJECTION OF LOT #1015022 OCCURRING THROUGH THE 6 MONTH VISIT ON (B)(6) 2010. THE PATIENT REPORTED A URINARY TRACT INFECTION ON (B)(6) 2011, WHICH WAS CONFIRMED BY URINALYSIS. THE PATIENT WAS TREATED WITH MACROBID 100 MG BID X 7 DAYS ON (B)(6) 2011. THE INFECTION RESOLVED ON (B)(6) 2011. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND DEFINITELY NOT DEVICE RELATED. ON (B)(6) 2011, AN ADDITIONAL INJECTION (BETWEEN THE 12 THROUGH 18 MONTH VISITS) WAS PERFORMED USING 2.5 ML OF LOT #1024083. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ AESTHETICS, INC. 1015022

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention