BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEKO NITRILE STANDARD EXAM GRADE GLOVE

    MDR report key: 13863877 · Received March 22, 2022

    Report

    Report Number
    MW5108480
    Event Type
    Malfunction
    Date Received
    March 22, 2022
    Date of Event
    March 14, 2022
    Report Date
    March 21, 2022
    Manufacturer
    UNK
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE WAS USING NITRILE GLOVE (SAFEKO) FOR BLOOD DRAW PROCEDURE. NURSE REMOVED GLOVE FROM BOX AND NOTICED UNUSUAL FEEL. UPON EXAMINATION NURSE FOUND GLOVE CUT AND VARIOUS PIECES OF POTTERY WERE FOUND IN GLOVE AND PROTRUDING THROUGH GLOVE. HNC ENTERPRISES, LLC (B)(4).. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310752 SAFEKO NITRILE STANDARD EXAM GRADE GLOVE POLYMER PATIENT EXAMINATION GLOVE LZA UNK SK-1021-NEF-BL-S-100 20-632-SB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown