BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSMA OPPORTUNITY FLEX AND GOOD WORKS GLOVES

    MDR report key: 23121086 · Received September 22, 2025

    Report

    Report Number
    MW5176321
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Report Date
    September 17, 2025
    Manufacturer
    BOSMA INDUSTRIES FOR THE BLIND, INC.
    Product Code
    QDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SINCE (B)(6) 2024, RECURRING QUALITY ISSUES HAVE BEEN REPORTED WITH BOSMA GOOD WORKS GLOVES, POSING A POTENTIAL STAFF SAFETY RISK. STAFF NOTED THAT MANY GLOVES ARRIVE TORN, STICK TOGETHER, OR TEAR EASILY WHEN DONNED, COMPROMISING BARRIER PROTECTION. SOME GLOVES ARE ALSO RECEIVED PRE-SOILED. AFTER NOTIFYING THE COMPANY, THE HOSPITAL TRANSITIONED TO BOSMA OPPORTUNITY FLEX GLOVES; HOWEVER, THE SAME ISSUES PERSISTED, CONTINUING TO PLACE STAFF AT RISK OF EXPOSURE. AN250211252 SIZE SMALL AN250411331, AN250511406, AN250211282- SIZE S AN250411407 SIZE M, AN250210952 SIZE M, AN250210949 SIZE M, AN250210949 SIZE M, AN241110951 SIZE S, AN241110950 SIZE M. REFERENCE REPORT MW5176317, MW5176318, MW5176319, MW5176320, MW5176322, MW5176323, MW5176324, MW5176325, MW5176326.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196207 BOSMA OPPORTUNITY FLEX AND GOOD WORKS GLOVES FENTANYL AND OTHER OPIOID PROTECTION GLOVE QDO BOSMA INDUSTRIES FOR THE BLIND, INC. AN250411407 SIZE M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other