BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALOETOUCH ICE GLOVES SIZE LARGE

    MDR report key: 11855062 · Received May 19, 2021

    Report

    Report Number
    MW5101452
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BOSMA INDUSTRIES FOR THE BLIND, INC
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    STAFF REPORTED ONE BOX OF BOSMA ALOE TOUCH ICE GLOVES SIZE LARGE THAT CONTAINED A SMALL GLASS SHARD INSIDE THE GLOVE. STAFF REPORTED A SMALL CUT TO FINGER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749171 ALOETOUCH ICE GLOVES SIZE LARGE POLYMER PATIENT EXAMINATION GLOVE LZA BOSMA INDUSTRIES FOR THE BLIND, INC 73-20303 AM201007023

    Patients

    Seq Age Sex Outcome Treatment
    1