BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 5189952 · Received October 29, 2015

    Report

    Report Number
    2135225-2015-00090
    Event Type
    Injury
    Date Received
    October 29, 2015
    Date of Event
    May 3, 2010
    Report Date
    September 29, 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. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2009 THE PATIENT WAS INJECTED WITH 2.0ML OF COAPTITE, LOTS 1011520 & 1010803. NO ADVERSE EVENT REPORTED. ON (B)(6) 2009 THE PATIENT WAS INJECTED WITH 3.0ML OF COAPTITE, LOT 1012109. ON (B)(6) 2010 THE PATIENT HAD A URINARY TRACT INFECTION (DIAGNOSED BY URINE C AND S). ON (B)(6) 2010 THE PATIENT WAS PRESCRIBED MACROBID 100MG BID X 7 DAYS, THEN 1 QHS #45. AS OF (B)(6) 2010 THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND PROBABLY NOT DEVICE RELATED. ON (B)(6) 2010 THE PATIENT WAS INJECTED WITH 3.0ML OF COAPTITE, LOT 1015082. ON (B)(6) 2010 THE PATIENT HAD A URINARY TRACT INFECTION (DIAGNOSED BY URINE C AND S). ON (B)(6) 2010 THE PATIENT WAS PRESCRIBED MACROBID 100MG BID X 7 DAYS, THEN 1 QHS #45. AS OF (B)(6) 2010 THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND PROBABLY NOT DEVICE RELATED. ON (B)(6) 2012 THE PATIENT HAD A URINARY TRACT INFECTION THAT WAS DIAGNOSED BY A URINALYSIS. ON (B)(6) 2012 THE PATIENT WAS PRESCRIBED CIPROFLOXACIN 400MG IVPB. THE PATIENT WAS ADMITTED AND CEFTRIAXONE WAS ADMINISTERED BY IV AS WELL AS ROCEPHIN IV. THE PATIENT WAS ALSO GIVEN OMNICEF 300MGPO BID. THE PHYSICIAN ASSESSED THE EVENT AS SEVERE AND PROBABLY NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720212 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1012109

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention