BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLUSION GLOVE PF LATEX GRAPE

    MDR report key: 2153078 · Received June 16, 2011

    Report

    Report Number
    2411236-2011-00002
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    PURNABIA ADVENTA HEALTH
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG #: 1032712. ADDITIONAL LOT #: 1010348.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT A STAFF MEMBER, FEMALE, (B)(6), WHO HAS A KNOWN ALLERGY (HYPERSENSITIVITY) TO LATEX, DEVELOPED SWELLING OF THE THROAT, AND DIFFICULTY BREATHING (DYSPNEA). SHE DID NOT WEAR THE GLOVES BUT OTHER STAFF MEMBERS WERE WEARING THESE GLOVES AROUND HER. SHE TOOK A BENADRYL BEFORE GOING TO THE HOSPITAL. THE HOSPITAL DID ADMINISTER A MEDICATION BUT NOT THROUGH AN IV. SHE WAS MONITORED AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUSION GLOVE PF LATEX GRAPE LATEX EXAMINATION GLOVE GRAPE LYY PURNABIA ADVENTA HEALTH 1010349

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other