BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE INJECTABLE IMPLANT

    MDR report key: 4223987 · Received October 29, 2014

    Report

    Report Number
    2135225-2014-00073
    Event Type
    Other
    Date Received
    October 29, 2014
    Date of Event
    November 23, 2011
    Report Date
    September 29, 2015
    Manufacturer
    MEZ NORTH AMERICA, INC.
    Product Code
    LNM
    PMA / PMN Number
    P040047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE URINARY TRACT INFECTIONS HAVE RESOLVED. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOTS WERE REVIEWED, ALL REQUIRED TESTING SPECS 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

    THE PATIENT WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2013 THE PATIENT WAS INJECTED WITH 2.0 ML OF COPATITE, LOT 1035202. ON (B)(6) 2011 THE PATIENT HAD A URINARY TRACT INFECTION THAT WAS DIAGNOSED BY A URINALYSIS. ON (B)(6) 2011 THE PATIENT WAS PRESCRIBED KEFLEX 250MG TID X 7 DAYS. AS OF (B)(6) 2011 THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS MILD AND POSSIBLY DEVICE RELATED.

    Description of Event or Problem · 1

    A PT (B)(6) WAS ENROLLED IN (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2010, THE PT WAS INJECTED WITH 2.0 ML COAPTITE, LOT 1018370. ON (B)(6) 2012, THE PT DEVELOPED URINARY TRACT INFECTION IDENTIFIED THROUGH URINALYSIS. ON (B)(6) 2012, THE PT WAS TREATED WITH ANTIBIOTIC CIPROFLOXACIN 250MG PO BID. THE ADVERSE EVENT RESOLVED ON (B)(6) 2013. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND PROBABLY NOT RELATED TO COAPTITE. ON (B)(6) 2013, THE PT DEVELOPED URINARY TRACT INFECTION REPORTED BY A PT. ON (B)(6) 2013, THE PT WAS TREATED WITH AN ANTIBIOTIC MACROBID 100 MG PO Q12HRS X 10M DAYS. THE ADVERSE EVENT RESOLVED ON (B)(6) 2013. PER PHYSICIAN, THE EVENT WAS OF MILD SEVERITY AND PROBABLY NOT RELATED TO COAPTITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692801 COAPTITE INJECTABLE IMPLANT INJECTABLE IMPLANT LNM MEZ NORTH AMERICA, INC. 1035202

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention