BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARMED ULTRA NITRILE EXAM GLOVE

    MDR report key: 12331134 · Received August 17, 2021

    Report

    Report Number
    12331134
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    August 4, 2021
    Report Date
    August 5, 2021
    Manufacturer
    SEMPERMED USA, INC.
    Product Code
    OPJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE STARMED ULTRA NITRILE EXAM GLOVES WERE REMOVED FROM BOX, IT WAS EVIDENT THAT THEY WERE ¿RIPPED¿ IN BOX- PRIOR TO REMOVAL. TWO SEPARATE EVENTS. (1) A GLOVE WAS REMOVED FROM THE BOX AND THE MEDIAL PART OF THE GLOVE WAS RIPPED. MFG DATE/LOT # 2020-12, L072306, 2021 (HAVE THE BOX AND GLOVE) SIZE LARGE. (2) A GLOVE WAS REMOVED FROM THE BOX ALREADY RIPPED. MFG DATE/LOT # 2021-02, L076327, 2102 (NOT SAVED). (B)(6). WILL LOOK INTO THE RECURRENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229552 STARMED ULTRA NITRILE EXAM GLOVE MEDICAL GLOVES WITH CHEMOTHERAPY LABELING CLAIMS OPJ SEMPERMED USA, INC. L072306

    Patients

    Seq Age Sex Outcome Treatment
    1