BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4122201 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-10989
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    October 5, 2012
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    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 APRIL 16, 2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. BRAND NAME: UNK. S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER. A USED SAMPLE WAS RECEIVED AT THE TESTING LAB. THE CONDITION OF THE SAMPLE WAS SUCH THAT A DEFINITIVE DETERMINATION THAT THE SAMPLE MET SPECIFICATION COULD NOT BE DETERMINED. A BATCH RECORD REVIEW WAS PERFORMED AND THE COMPONENTS USED TO ASSEMBLE THE ADHESIVES WERE APPROVED FOR USE; THERE WAS NO OBJECTIVE EVIDENCE OF DISCREPANCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A PT CHANGED HER WAFER SHE NOTED BLOOD ON HER SKIN; THE WAFER HAD CUT INTO HER STOMA AT THE 3-5 O CLOCK AREA. SHE DESCRIBED A SHIFTING OR MOVING OF THE WAFER TO THE RIGHT DURING HER WEAR TIME. THE AMOUNT OF BLOOD WAS MINIMAL AND BLEEDING STOPPED WITH ROUTINE CLEANING; IT IS ALSO REPORTED THAT THE PT DISCONTINUED USE OF THE PRODUCT. NO ADDITIONAL INFO WAS PROVIDED. PT OUTCOME IS REPORTED AS THE "BLEEDING STOPPED WITH ROUTINE CLEANING AND APPLYING A WASH CLOTH TO THE STOMA AREA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575787 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) PROTECTOR, OSTOMY EXE CONVATEC, INC. 404593 2A03846

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention