BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCUTOUCH (POWDER FREE)

    MDR report key: 457392 · Received May 1, 2003

    Report

    Report Number
    8040688-2003-00001
    Event Type
    Other
    Date Received
    May 1, 2003
    Date of Event
    March 11, 2003
    Report Date
    May 1, 2003
    Manufacturer
    TILLOTSON HEALTHCARE CORP.
    Product Code
    LYY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER TRIED GLOVE PRODUCT FOR THE FIRST TIME. WITHIN 10 MINUTES, USER DEVELOPED A RASH ON HANDS THAT SPREAD UP ARM. USER THEN EXPERIENCED DIFFICULTY BREATHING AND WAS SENT TO THE CLINIC TO BE TREATED FOR ANAPHYLACTIC SYMPTOMS. USER WAS GIVEN EPIBARE AND WAS TREATED AS AN OUTPATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUTOUCH (POWDER FREE) LATEX EXAMINATION GLOVES LYY TILLOTSON HEALTHCARE CORP. 02-4303 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention