BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 3429644 · Received October 17, 2013

    Report

    Report Number
    2135225-2013-00141
    Event Type
    Other
    Date Received
    October 17, 2013
    Date of Event
    October 9, 2012
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR LOT 1033553 WERE REVIEWED, ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    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 2.0 ML COAPTITE, LOT 1033553. ON (B)(6) 2012, THE PATIENT DEVELOPED URINARY RETENTION DIAGNOSED BY A BLADDER SCAN. THE PATIENT WAS TREATED WITH FOLEY CATHETERIZATION STARTING ON (B)(6) 2012. THE ADVERSE EVENT RESOLVED ON (B)(6) 2012. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND DEFINITELY RELATED TO COAPTITE.

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2012 THE PATIENT WAS INJECTED WITH 2.0ML OF COAPTITE, LOT 1033926. ON (B)(6) 2012 THE PATIENT REPORTED A URINARY TRACT INFECTION. ON (B)(6) 2012 THE PATIENT WAS PRESCRIBED MACROBID (DOSE & DURATION NOT PROVIDED). AS OF (B)(6) 2012 THE EVENT WAS RESOLVED AND THE PATIENT WAS INJECTED WITH 2.0ML OF COAPTITE. THE PHYSICIAN ASSESSED THE CASE AS MILD AND DEFINITELY NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533614 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MERZ NORTH AMERICA, INC. 1033926

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention