BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4S/SUR-FIT NATURA 2PC - 2PC DURAHESIVE (DH)

    MDR report key: 4053554 · Received August 27, 2014

    Report

    Report Number
    1049092-2014-10367
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    November 24, 2011
    Report Date
    November 28, 2011
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED 04/16/2014. 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. ANALYSIS IS TAKEN FROM 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.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT CUSTOMER REPORTED "INTACT RASH UNDER BOTH WAFER AND TAPE COLLAR EXTENDING OUTWARD 1 INCH". THE PATIENT EXPERIENCED THE CONDITION DURING A PERIOD OF FOUR DAYS PRIOR TO COMPLAINT RECEIPT. CUSTOMER IS USING ADHESIVE REMOVER; SOAP; AND SKIN PREP WITH BELT. PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522619 S4S/SUR-FIT NATURA 2PC - 2PC DURAHESIVE (DH) EXE CONVATEC, INC. 104593 1E01038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention