BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4S/SUR-FIT NATURA 2PC-2PC STOMAHESIVE (SH)

    MDR report key: 4012506 · Received August 12, 2014

    Report

    Report Number
    1049092-2014-10162
    Event Type
    Injury
    Date Received
    August 12, 2014
    Report Date
    August 8, 2011
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K800750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 (B)(4) ISSUED (B)(4) 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 (B)(6) 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS. THE BRAND NAME SHOULD READ AS S4S/SUR-FIT NATURA 2PC-2PC STOMAHESIVE (SH) MOLDABLE WAFER.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT END USER SKIN UNDER THE TAPE COLLAR HAD BECOME ITCHY AND, AT TIMES, DEVELOPED PINPOINT RASH. THE PATIENTS SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478837 S4S/SUR-FIT NATURA 2PC-2PC STOMAHESIVE (SH) PROTECTOR, OSTOMY EXE CONVATEC INC. 411805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention