BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA LPC WAFER, 57MM DURAHESIVE CMT, 22-33M

    MDR report key: 4101741 · Received September 15, 2014

    Report

    Report Number
    1049092-2014-00480
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    September 2, 2013
    Report Date
    September 2, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE SERIOUS INJURY. END USER REPORTS CURRENT SKIN CARE CONSISTS OF STOMAHESIVE POWDER AND WIPES FOR CRUSTING AND AQUACEL DRESSING COVERED WITH THIN DUODERM PER WOUND OSTOMY CONTINENCE NURSE AND PHYSICIANS ORDER. END USER REPORTS SEEING LOCAL WOUND OSTOMY CONTINENCE NURSE AND PHYSICIAN ROUTINELY. END USE IS REQUESTING A LARGER SIZE WAFER THAT COVERS THE WOUND AND DRESSINGS FULLY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. NO SAMPLE IS EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    END USER REPORTS A 1 YEAR HISTORY OF OPEN AREA UNDER STOMA. THIS AREA IS AT 12 O'CLOCK POSITION RIGHT ABOVE STOMA ABOUT 1 INCH IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570172 NATURA LPC WAFER, 57MM DURAHESIVE CMT, 22-33M PROTECTOR, OSTOMY EXE CONVATEC INC 421040 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention