BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODWORKS FENTANYL SAFE GLOVES

    MDR report key: 21994111 · Received May 9, 2025

    Report

    Report Number
    MW5170166
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 2, 2025
    Manufacturer
    BOSMA INDUSTRIES FOR THE BLIND, INC.
    Product Code
    QDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CBOC (COMMUNITY-BASED OUTPATIENT CLINIC) LPN (LICENSED PRACTICAL NURSE) IDENTIFIED POOR QUALITY OF THE GOODWORKS SIZE SMALL FENTANYL SAFE GLOVES- LOT #S-AN241010944 AND AN250111141. THE GLOVES ARE THIN AND COMING OUT OF THE BOX KNOTTED IN AREAS AND EASILY RIPPING WHEN DONNING THE GLOVES". REF REPORT: MW5170165.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347467 GOODWORKS FENTANYL SAFE GLOVES FENTANYL AND OTHER OPIOID PROTECTION GLOVE QDO BOSMA INDUSTRIES FOR THE BLIND, INC. AN250111141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other