BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE LIFE PCH DRN F STDCLR19MM

    MDR report key: 5135832 · Received October 8, 2015

    Report

    Report Number
    9618003-2015-30543
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    June 25, 2014
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC DOM. REPUBLIC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-001-PRO AND PROTOCOL 2015-002-PRO. CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    IT WAS REPORTED A LEAKAGE DUE TO SHARP CUTTING EDGE AT THE SEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665357 ACTIVE LIFE PCH DRN F STDCLR19MM POUCH, COLOSTOMY EZQ CONVATEC DOM. REPUBLIC 400394

    Patients

    Seq Age Sex Outcome Treatment
    1