BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSMA ALOE TOUCH ICE

    MDR report key: 12307017 · Received August 10, 2021

    Report

    Report Number
    MW5103142
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Report Date
    August 6, 2021
    Manufacturer
    BOSMA INDUSTRIES FOR THE BLIND, INC.
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    STAFF REPORTED A SKIN REACTION WITH RASH ON HANDS FOLLOWING 2 MINUTES OF USE OF GLOVES. HANDS FELT ITCHY, TOOK GLOVES OFF, BOTH HANDS WERE RED AND SLIGHTLY SWOLLEN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197090 BOSMA ALOE TOUCH ICE SURGEON'S GLOVE KGO BOSMA INDUSTRIES FOR THE BLIND, INC. 73-20302 AM200706826

    Patients

    Seq Age Sex Outcome Treatment
    1