BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 OC DURAHESIVE CONVEX WAFER

    MDR report key: 3550443 · Received December 26, 2013

    Report

    Report Number
    1049092-2013-00415
    Event Type
    Injury
    Date Received
    December 26, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 2, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. THREE WRITTEN REQUESTS HAVE BEEN MADE ON (B)(4) 2013 TO OBTAIN ADD'L CUSTOMER INFO. NO ADD'L PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFO REC'D AS FOLLOWS: REFERRED BY 180 MEDICAL AS HAVING IRRITATION BENEATH MASS OR TAPE BORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676268 NATURA 2 OC DURAHESIVE CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 404593 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1