BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 5176072 · Received October 25, 2015

    Report

    Report Number
    2135225-2015-00080
    Event Type
    Injury
    Date Received
    October 25, 2015
    Date of Event
    May 11, 2012
    Report Date
    September 25, 2015
    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

    THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE. THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PATIENT ((B)(6)) WAS ENROLLED IN THE POST-APPROVAL COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2012, THE PATIENT WAS INJECTED WITH A TOTAL OF 3.0ML OF COAPTITE, LOTS 1031234, 1030939. ON (B)(6) 2012, THE PATIENT WAS INJECTED WITH A TOTAL OF 2.0ML OF COAPTITE, LOT 1033386. ON (B)(6) 2013, THE PATIENT WAS INJECTED WITH A TOTAL OF 2.0ML OF COAPTITE, LOT 1035202. ON (B)(6) 2012 A URINALYSIS WAS PERFORMED AND THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION. THE PATIENT WAS TREATED WITH NITROFURANTOIN. ON (B)(6) 2012 THE NITROFURANTOIN WAS DISCONTINUED AND THE PATIENT WAS STARTED ON KEFLEX 500MG X 3 DAYS. THE EVENT RESOLVED ON (B)(6) 2012. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND POSSIBLY DEVICE RELATED. ON (B)(6) 2012 THE PATIENT HAD URINARY RETENTION THAT WAS DIAGNOSED BY EMR PI. A FOLEY CATHETER WAS IMPLANTED. ON (B)(6) 2012 THE PATIENT REMOVED THE CATHETER AT HOME & HAD NO VOIDING ISSUES IN EMR WITH REMOVAL. THE EVENT RESOLVED ON (B)(6) 2012. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND DEFINITELY DEVICE RELATED. ON (B)(6) 2012 THE PATIENT HAD A URINARY TRACT INFECTION THAT WAS DIAGNOSED BY A URINALYSIS AND EMR. ON (B)(6) 2012 THE PATIENT WAS PRESCRIBED ON CIPRO. ON (B)(6) 2012 A URINE CULTURE WAS DONE AND NO ORGANISMS WERE ISOLATED. THE EVENT RESOLVED ON (B)(6) 2012. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND POSSIBLY DEVICE RELATED. ON (B)(6) 2012 THE PATIENT HAD ACUTE CYSTITIS THAT WAS DIAGNOSED BY EMR. ON (B)(6) 2012 THE PATIENT WAS PRESCRIBED ON CIPRO 250MG BID X 7 DAYS. ON (B)(6) 2012 THE PATIENT WAS STARTED ON MACROBID 1 PO BID THEN QHS #60. THE EVENT RESOLVED ON (B)(6) 2012. ON (B)(6) 2013 THE PATIENT WAS HAD A URINARY TRACT INFECTION THAT WAS DIAGNOSED BY THE PHYSICIAN. ON (B)(6) 2013 THE PATIENT WAS PRESCRIBED ZOSYN 4.5G IVQ 12. THE EVENT RESOLVED ON (B)(6) 2013. THE PHYSICIAN ASSESSED THE EVENT AS MODERATE AND POSSIBLY DEVICE RELATED. ON (B)(6) 2013 THE PATIENT HAD A URINARY TRACT INFECTION THAT WAS DIAGNOSED BY EMR. ON (B)(6) 2013 THE PATIENT WAS PRESCRIBED BACTRIM DS BID X 7 DAYS. THE EVENT RESOLVED ON (B)(6) 2013. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND POSSIBLY DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706451 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1031234

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention