BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSTA GARD YELLOW ISOLATION MASK

    MDR report key: 1653529 · Received April 7, 2010

    Report

    Report Number
    1423507-2010-00016
    Event Type
    Other
    Date Received
    April 7, 2010
    Date of Event
    February 5, 2010
    Report Date
    March 17, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. NO SAMPLE WAS PROVIDED. WITHOUT THE LOT NUMBER OR THE SAMPLE, WE ARE UNABLE TO ASSIGN A ROOT CAUSE. DURING THE PRODUCT DEVELOPMENT PHASE, ALL MATERIALS USED IN THIS MASK WERE EVALUATED FOR BIOCOMPATIBILITY. THE TESTING WAS PERFORMED IN ACCORDANCE WITH INTERNATIONAL STANDARD IOS 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. UNFORTUNATELY NO TEST OR SERIES OF TESTS CAN GUARANTEE THAT A PARTICULAR ITEM WILL BE COMPATIBLE WITH ALL USERS. NO CHANGES HAVE BEEN MADE IN THE MANUFACTURING PROCESS FOR THIS PRODUCT THAT WOULD ACCOUNT FOR THIS TYPE OF EVENT. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    A RESPIRATORY THERAPIST DEVELOPED A RASH WITH SEVERE ITCHING. THE RASH LOOKED SIMILAR TO HIVES, AND SPREAD TO HER NECK/CHEST/UPPER BACK/UPPER ARMS. SHE SAW SEVERAL PHYSICIANS AND RECEIVED TREATMENT AND WAS GIVEN MEDICATIONS. PRESENTLY, SHE IS NOT HAVING ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTA GARD YELLOW ISOLATION MASK ISOLATION MASK LGM CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other