BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4122234 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-11002
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    October 11, 2012
    Manufacturer
    CONVATEC, INC
    Product Code
    EXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 (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. IT IS NOTED THAT THERE ARE BLANK AREAS ON THIS FORM, THE INFORMATION WAS NOT PROVIDED OR IS UNKNOWN. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED (B)(4) 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

    IT WAS REPORTED THAT PATIENT HAD A RASH ON HIS ABDOMEN FEW WEEKS WHILE IN THE HOSPITAL; HE WAS GIVEN A MEDICATION, BUT HAS NOT USED IT. THE RASH INCREASED AND SPREAD BENEATH THE WAFER AND POUCH, AND REPORTED A ITCHING. THE PATIENT WAS ENCOURAGED TO USE THE MEDICATION GIVEN TO HIM IN THE HOSPITAL WITH THE PROTECTIVE BARRIER AND CHANGE THE WAFER MORE OFTEN UNTIL THE AREA CLEARS. THE PATIENT WAS ALSO ENCOURAGED TO CONTACT A PHYSICIAN IF THERE WAS NO IMPROVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT OUTCOME IS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576017 S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC 404593

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention