BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 13846469 · Received March 22, 2022

    Report

    Report Number
    13846469
    Event Type
    Malfunction
    Date Received
    March 22, 2022
    Date of Event
    March 8, 2022
    Report Date
    March 10, 2022
    Manufacturer
    SEMPERMED USA, INC.
    Product Code
    OPJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT TO WOUND CARE FOR CARE, UPON OBTAINING A GLOVE FROM THE BOX, IT WAS EVIDENT THAT THERE WERE 3 HOLES IN THE THUMB. PROCEDURE- CHANGING A DRESSING IN WOUND CARE. GLOVE NOT USED- SAVED AND REPORTED. NO HARM TO EMPLOYEE OR PATIENT. MANUFACTURER RESPONSE FOR EXAMINATION GLOVE, STARMED ULTRA NITRILE. COMPANY STATES THAT THEY COULD NOT DO ANYTHING WITHOUT A SIGNIFICANT VOLUME OF GLOVES WITH HOLES PER BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20606 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY LABELING CLAIMS-TEST FOR USE WITH CHEMO DRUGS OPJ SEMPERMED USA, INC. SMTN254

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown