BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFETEC

    MDR report key: 213871 · Received March 2, 1999

    Report

    Report Number
    MW1015868
    Event Type
    Injury
    Date Received
    March 2, 1999
    Date of Event
    December 5, 1998
    Report Date
    February 22, 1999
    Manufacturer
    SAFETEC OF AMERICA, INC.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR HAD AN ANAPHYLACTIC ALLERGIC REACTION TO GLOVES AT WORK. RPTR IS AN RN. THIS WAS LATER DIAGNOSED AS A TYPE I LATEX ALLERGY. RPTR HAS BEEN REMOVED FROM PT CARE IN ORDER TO KEEP HER FROM HAVING FURTHER REACTIONS. RPTR MAY BE REQUIRED TO LEAVE HOSP ALTOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETEC LATEX GLOVE LYY SAFETEC OF AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R| S NITRILE GLOVES, TESTED NEGATIVE TO THIS.