BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVELIFE

    MDR report key: 8209588 · Received January 2, 2019

    Report

    Report Number
    9618003-2019-00041
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED.  THEREFORE, THIS EVALUATION WILL BE CLOSED.  THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE POUCH PRE CUT OPENING WAS OFF CENTER WHICH CREATED LEAKS." NO HARM REPORTED. NO PHOTOS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512 ACTIVELIFE POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC INC 125353

    Patients

    Seq Age Sex Outcome Treatment
    1 63