BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4012505 · Received August 12, 2014

    Report

    Report Number
    9618003-2014-10158
    Event Type
    Injury
    Date Received
    August 12, 2014
    Report Date
    August 5, 2011
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE RETAINED PRODUCT WAS EVALUATED AND THE EVALUATION RESULTS ARE AS FOLLOWS: THE SAMPLES WERE VISUALLY INSPECTED AND ALL SAMPLES APPEARED TO BE IN NORMAL CONDITION. LEAK TESTING WAS PERFORMED AND PASSES THE ESTABLISHED SPECIFICATION. THERE IS NO INDICATION OF ANY NONCONFORMANCES OR CAPAS RELATED TO THIS ISSUE. THE BRAND NAME SHOULD READ AS S4S/SUR-FIT NATURA 2PC-2PC STOMAHESIVE (SH) FLEXIBLE WAFER.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT THE END USER HAD DEVELOPED A RASH UNDER THE WHOLE MASS. PATIENT EXPERIENCED THE CONDITION DURING AN UNKNOWN PERIOD PRIOR TO COMPLAINT RECEIPT. THE PATIENTS SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478940 S4S/SUR-FIT NATURA 2PC-2PC STOAHESIVE (SH) PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC, INC. 402219 1A02036

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention