BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAPAROTOMY PACK, TIBURON

    MDR report key: 1576696 · Received December 31, 2009

    Report

    Report Number
    1423507-2009-00111
    Event Type
    Other
    Date Received
    December 31, 2009
    Date of Event
    December 7, 2009
    Report Date
    December 29, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FYA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS UNABLE TO PROVIDE THE SAMPLE. TRENDING WAS DONE. DURING THE PRODUCT DEVELOPMENT PHASE, ALL MATERIALS USED FOR THE GOWN WERE EVALUATED FOR BIOCOMPATIBILITY. THE TESTING WAS PERFORMED IN ACCORDANCE WITH INTERNATIONAL STANDARD ISO 10993 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. ONLY MATERIALS THAT SUCCESSFULLY COMPLETE THESE TESTS CAN BE COMMERCIALIZED. THE TESTS UTILIZED ARE DESIGNED TO PREDICT THE SAFETY OF THE PRODUCT FOR THE GENERAL POPULATION OF USERS. HOWEVER, NO TEST OR SERIES OF TESTS CAN GUARANTEE THAT A PARTICULAR ITEM WILL BE COMPATIBLE WITH ALL USERS. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    TWO INDIVIDUALS EXPERIENCED SEVERE FOREARM BREAK-OUTS AND SKIN IRRITATION AFTER WEARING THE GOWN (CATALOG # 9011) IN THE LAPAROTOMY PACK. ONE INDIVIDUAL ( A SURGEON), NEEDED PRESCRIPTIVE STEROID OINTMENT. THE OTHER INDIVIDUAL (OR TECH) DID NOT REQUIRE MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROTOMY PACK, TIBURON LAPAROTOMY PACK, TIBURON FYA CARDINAL HEALTH 09KFH769

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other