BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSMA ENTERPRISES

    MDR report key: 23591312 · Received November 19, 2025

    Report

    Report Number
    23591312
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    August 21, 2025
    Report Date
    November 12, 2025
    Manufacturer
    BOSMA INDUSTRIES FOR THE BLIND, INC.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OVER 81 REPORTS ACROSS THE COUNTRY RECEIVED BY OUR OFFICE IN REGARDS TO BOSMA GLOVES. NUMEROUS FACILITIES REPORTED ISSUES WITH THE BOSMA GLOVES OF NUMEROUS SIZES AND LOTS MENTIONING THAT THEY ARE EASILY TEARING WHEN PUTTING ON. OTHER FACILITIES REPORTED GLOVES WERE TORN WHEN THEY WERE TAKEN OUT THE BOX, BEFORE PUTTING THEM ON. OTHER REPORTS MENTIONED FINGERS WERE MISSING OFF THE GLOVES. NUMEROUS REPORTS MENTIONED GLOVES WERE ALSO THINNER AND THIS HAS CAUSES NEEDLES TO SLIP INCREASING POTENTIAL FOR NEEDLE STICKS AND HARM TO HEALTHCARE PROVIDERS. STAFF ARE REPORTING "ABOUT EVERY 3RD GLOVE TEARS WHEN REMOVING FROM BOX AND MANY ARE DEFECTIVE COMING OUT OF THE BOX (TEARS, HOLES, MISSING 'CHUNKS' OF THE GLOVE, MISSING FINGERS, FINGERS/THUMB LOCATED IN THE WRONG PLACE). THIS LACK OF QUALITY PLACES BOTH THE PATIENT AND STAFF AT RISK FOR INFECTION. MANUFACTURER RESPONSE FOR BOSMA GLOVES, BOSMA (PER SITE REPORTER). MANUFACTURER HAS OFFERED TO REPLACE PRODUCTS WITH NO IMPROVEMENT IN QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2883299 BOSMA ENTERPRISES POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE LZA BOSMA INDUSTRIES FOR THE BLIND, INC. 72-50900 LOTS INVOLVED FROM ALL SIZES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown