BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 4223990 · Received October 29, 2014

    Report

    Report Number
    2135225-2014-00079
    Event Type
    Other
    Date Received
    October 29, 2014
    Date of Event
    October 17, 2012
    Report Date
    October 1, 2014
    Manufacturer
    MERZ NORTH AMERICA, 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

    ADDITIONAL LOTS USED FOR INJECTION ON (B)(6) 2009: #1010488 (EXP 07/2011, MFR DATE 07/2008), #1010803 (EXP 10/2011, MFR DATE 10/2008). IMPLANT DATE: (B)(6) 2009. AT THE TIME OF THIS REPORT, THE PT'S UTI HAD RESOLVED. THE DEVICE HISTORY RECORDS FOR THE 3 REPORTED LOTS WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE WITH 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 WITH 1.5 ML OF COAPTITE LOT 31012957 (2) ON (B)(6) 2009 WITHOUT ISSUE. THE PT WAS INJECTED A SECOND TIME ON (B)(6) 2009 WITH 2.0 ML OF LOT #1010448 AND 1.0 ML OF LOT #1010803. THE PT DEVELOPED A URINARY TRACT INFECTION DIAGNOSED BY URINALYSIS ON (B)(6) 2010. THE PT WAS TREATED WITH MACROBID STARTING (B)(6) 2010. THE INFECTION RESOLVED ON (B)(6) 2010. THE PHYSICIAN ASSESSED THE EVENT AS MILD IN SEVERITY AND PROBABLY NO DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692803 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC 1012957

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention