BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA STOMAHESIVE FLEXIBLE SKIN BARRIER W/FLANGE W/WHITE TAPE CAOLLAR A

    MDR report key: 4100852 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11045
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    October 29, 2012
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS TAKEN FORM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS. CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED APRIL 16, 2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE PT REPORTED SHE DEVELOPED A WEEPING RASH UNDER THE WAFER. THE RASH HAS PERSISTED FOR APPROXIMATELY ONE MONTH. INITIALLY, THE RASH APPEARED ON THE LEFT SIDE OF THE STOMA AFTER THE PT EXPERIENCED A STOOL LEAKAGE. THE RASH HAS SINCE SPREAD AROUND BOTH SIDES OF THE STOMA. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565146 SUR-FIT NATURA STOMAHESIVE FLEXIBLE SKIN BARRIER W/FLANGE W/WHITE TAPE CAOLLAR A PROTECTOR, OSTOMY EXE CONVATEC, INC. 125261 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other