BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 15326882 · Received August 31, 2022

    Report

    Report Number
    15326882
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    May 25, 2022
    Report Date
    August 19, 2022
    Manufacturer
    SEMPERMED USA, INC.
    Product Code
    OPJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN NOTICED GLOVE STUCK TOGETHER WITH WHITE SUBSTANCE. MANUFACTURER RESPONSE FOR NITRILE GLOVES, STARMED ULTRA NITRILE (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED VIA EMAIL TO MANUFACTURER. FOLLOW-UP RECEIVED BY REGIONAL SALES MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067661 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY LABELING CLAIMS OPJ SEMPERMED USA, INC. SMTN253 L0029182108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown