BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4023927 · Received August 14, 2014

    Report

    Report Number
    9618003-2014-10558
    Event Type
    Injury
    Date Received
    August 14, 2014
    Report Date
    March 20, 2012
    Manufacturer
    CONVATEC DOM. REPUBLIC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    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 483 ISSUED APRIL 16, 2014. DEVICES 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. THE BATCH RECORD REVIEW FOR LOT 1K01539 WAS PERFORMED. THIS PRODUCT WAS MANUFACTURED ACCORDING TO THE QUALITY SYSTEM AND APPROVED PROCEDURES IN PLACE AT THE TIME OF MANUFACTURING AND PACKAGING. THE BATCH RECORD REVIEW FOUND NO OBJECTIVE EVIDENCE OF DEVIATIONS, NON CONFORMANCES OR DISCREPANCIES RELATED TO THE COMPLAINT ISSUES REPORTED. AFTER INVESTIGATION, IT WAS FOUND THAT MATERIAL NUMBER (B)(4) ALIGNS WITH MODEL NUMBER: 413163, EXPIRATION DATE: 10/29/2016 AND DEVICE MANUFACTURE DATE: 10/31/2011.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THE PATIENT HAD A RED AND PURPLE BLOTCHY AREA OF PERISTOMAL SKIN, APPROXIMATELY ONE INCH IN DIAMETER UNDER THE WHITE TAPE COLLAR FOR OVER A MONTH. THE PATIENT HAS A HERNIA AND WEARS A HERNIA BELT. NO FURTHER INFORMATION WAS PROVIDED AND THE PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486262 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) PROTECTOR, OSTOMY EXE CONVATEC DOM. REPUBLIC, INC. 413163 1K01539

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention