BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/FLEXIBLE COLLAR

    MDR report key: 4132814 · Received September 29, 2014

    Report

    Report Number
    1049092-2014-11226
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    December 2, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED (B)(4) 2011. THE DATA PRESENTED IS FROM (B)(4) DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS. AFTER FURTHER INVESTIGATION, THE INITIAL LOT INFORMATION OBTAINED WAS DETERMINED AS INVALID UNDER THE CURRENT SYSTEM.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THE PATIENT DEVELOPED REDNESS BENEATH THE TAPE BORDER. THE PATIENT EXPERIENCED THIS CONDITION DURING A PERIOD OF TWO MONTHS PRIOR TO COMPLAINT RECEIPT. CONDITION SLIGHTLY IMPROVED THROUGH USE OF MEDICATED POWDER. PATIENT OUTCOME WAS NOT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606078 S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/FLEXIBLE COLLAR PROTECTOR, OSTOMY EXE CONVATEC INC. 125260

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention