BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE MODABLE WAFER

    MDR report key: 4123014 · Received September 3, 2014

    Report

    Report Number
    1049092-2014-00510
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. END USER REPORTS A TWO DAYS WEAR TIME AND APPLYING STOMAHESIVE PASTE TO DIP AREA WHERE OPEN AREA DEVELOPS. PER END USER, DOCTOR HAS CAUTERIZED THE AREA THREE TIMES IN THE PAST. THE AREA HEALS WHEN CAUTERIZED THEN OPENS AGAIN AT A LATER TIME. END USER ADVISED TO FOLLOW UP WITH HEALTH CARE PHYSICIAN. NO ADDITIONAL INFO HAS BEEN PROVIDED TO DATE. NO SAMPLE IS EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4). THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY END USER OF AN OPEN AREA TO LEFT OF STOMA THAT IS DIME SIZE AND OPENS AND CLOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536794 SUR-FIT NATURA 2 PC DURAHESIVE MODABLE WAFER PROTECTOR, OSTOMY, 78 EXE EXE CONVATEC INC. 411802 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1