BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 3429653 · Received October 17, 2013

    Report

    Report Number
    2135225-2013-00107
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    November 1, 2011
    Report Date
    September 20, 2013
    Manufacturer
    MERZ NORTH AMERICA, 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

    ADD'L LOT NUMBER 1024673, EXPIRATION DATE: 03/2014. IMPLANTED DATE: (B)(6) 2011. MANUFACTURE DATE: 03/2011. THE DEVICE HISTORY RECORDS FOR LOTS 1022220 AND 0124673 WERE REVIEWED, ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    PT ((B)(6)) WAS ENROLLED IN THE POST-APPROVAL COAPTITE INJECTABLE IMPLANT STUDY OF STRESS URINARY INCONTINENCE. ON (B)(6) 2011, THE PT WAS INJECTED IN TWO SITES WITH 1.0 ML COAPTITE, LOT 1022220. ON (B)(6) 2011, THE PT WAS INJECTED IN THREE SITES WITH 1.0 ML COAPTITE, LOT 1024673. ON (B)(6) 2011, THE PT DEVELOPED A URINARY TRACT INFECTION. THE PT WAS TREATED WITH MACROBID ON (B)(6) 2011 FROM PCP. THE ADVERSE EVENT RESOLVED ON (B)(6) 2011. PER PHYSICIAN THE EVENT WAS OF MILD SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE. ON (B)(6) 2012, THE PT DEVELOPED URGE INCONTINENCE. THE PT WAS TREATED WITH OXYBUTYNIN ANTICHOLINERGIC MEDICATION. PER PHYSICIAN THE EVENT WAS OF MILD SEVERITY AND DEFINITELY NOT RELATED TO COAPTITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532345 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC 1022220

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention