BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOOD WORKS GLOVES

    MDR report key: 22003313 · Received May 12, 2025

    Report

    Report Number
    MW5170201
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BOSMA INDUSTRIES FOR THE BLIND, INC.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GOOD WORKS GLOVES FOUND TO CONTAIN GLOVES WITH HOLES AND TEARS. THREE BOXES OF GOOD WORKS GLOVES FOUND TO CONTAIN GLOVES WITH HOLES AND TEARS. LOT AN241211071 (MEDIUM) AND LOT AN250211244. LOGISTICS NOTIFIED, ALL GLOVES WITH THESE LOT NUMBERS REMOVED FROM ICU STORAGE AND PATIENT ROOMS. LOGISTICS REPORTED PULLED LOT NUMBERS FROM CENTRAL SUPPLY. LAST MONTH, SAME CONCERN WITH LOT AN250211184 (MEDIUM) WAS REPORTED AND ADDRESSED. EMAIL SENT TO THE MANUFACTURE. REF REPORTS: MW5170202, MW5170203.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241145 GOOD WORKS GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA BOSMA INDUSTRIES FOR THE BLIND, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown