BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-FIT AUTOLOCK DH FLEXIBLE SKIN BARRIER

    MDR report key: 777169 · Received November 3, 2006

    Report

    Report Number
    2243969-2006-00023
    Event Type
    Malfunction
    Date Received
    November 3, 2006
    Date of Event
    October 5, 2006
    Report Date
    October 5, 2006
    Manufacturer
    CONVATEC
    Product Code
    EZR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS 2243969-2006-000023 & 2243969-2006-000024 REFER TO THE SAME EVENT. CONVATEC IS NOT CERTAIN AS TO THE IDENTITY OF THE DEBRIS FOUND IN THIS PATIENT'S CATHETER OR IF ANY UNTOWARD MEDICAL EVENTS AROSE AS A RESULT OF IT. THIS EVENT IS BEING REPORTED AS A DUE DILIGENCE MEASURE WHILE FURTHER CASE INVESTIGATION AND ANALYSIS CONTINUES ON THE DEBRIS SAMPLES EXPECTED TO BE SENT TO CONVATEC.

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: FOREIGN MATERIAL WAS FOUND FROM PATIENT'S BODY. SAMPLE WILL BE SENT TO CONVATEC HEADQUARTERS FOR TESTING. DUE TO CALCULUS FOUND IN BOTH RENAL PELVIS, PNL WAS CONDUCTED. FOREIGN MATERIAL WAS FOUND FROM RIGHT RENAL PELVIS, WHEN PNL WAS DONE. NO ADVERSE EVENT WAS REPORTED. FURTHER DETAIL WILL BE ADDED, WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUR-FIT AUTOLOCK DH FLEXIBLE SKIN BARRIER OSTOMY WAFER EZR CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other