BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVELIFE CONVEX ONE-PIECE PRE-CUT POUCH

    MDR report key: 6095589 · Received November 11, 2016

    Report

    Report Number
    1049092-2016-00041
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Report Date
    September 15, 2016
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL EMDR IS BEING RE-SUBMITTED PER REQUEST OF FDA ON 03-MAY-2021. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 28-SEP-2016 ON 25-OCT-2016, THE FOLLOWING INFORMATION WAS RECEIVED: A BATCH RECORD REVIEW FOUND NO DISCREPANCIES RELATED TO THE REPORTED COMPLAINT. PROCESS CHECKS AND QUALITY CHECKS WERE PERFORMED AND YIELDED ACCEPTABLE RESULTS. NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. THE ISSUE WILL BE MONITORED THROUGH THE POST MARKET MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 11-NOV-2016 (B)(4).

    Description of Event or Problem · 1

    THE END USER REPORTED THAT HE TRIED THE CONVEX ONE-PIECE APPROXIMATELY ONE YEAR AGO BUT THE OPENING WAS NOT LARGE ENOUGH SO HE CUT THE OPENING. AFTER APPLYING THE WAFER, HE NOTED BLEEDING FROM THE STOMA. HE STATED HE DID NOT SEE A LACERATION BUT SURMISES THAT THE JAGGED EDGES FROM CUTTING THE OPENING CAUSED THE BLEEDING. HE DID NOT SEE A PHYSICIAN AS THE BLEEDING RESOLVED QUICKLY WITHOUT TREATMENT ONCE THE POUCH WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748952 ACTIVELIFE CONVEX ONE-PIECE PRE-CUT POUCH POUCH, COLOSTOMY EZQ CONVATEC INC. 175779 3K01407

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male