BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEGUARD RADIATION ATTENUATING GLOVES

    MDR report key: 9472987 · Received December 13, 2019

    Report

    Report Number
    MW5091677
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 12, 2019
    Manufacturer
    EMERSON & CO., S. R. L.
    Product Code
    IWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FREEGUARD RADIATION ATTENUATING SURGICAL GLOVES HAD LARGE VISIBLE HOLES UPON OPENING OF STERILE PACKAGING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264761 FREEGUARD RADIATION ATTENUATING GLOVES RADIOGRAPHIC PROTECTIVE GLOVE IWP EMERSON & CO., S. R. L. MODEL 2, SIZE 8 121216

    Patients

    Seq Age Sex Outcome Treatment
    1