BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOVE, EXAM, NITRILE, PF, W/ FILM, S

    MDR report key: 19242753 · Received May 3, 2024

    Report

    Report Number
    1417592-2024-00570
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 3, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "ONE TECH HAD A SEVERE REACTION ON THE FACE AND HANDS FOR MULTIPLE DAYS AND WAS UNDER THE CARE OF A CLINICIAN BECAUSE HER REACTION WAS SO SEVERE. URGENT CARE GAVE STEROID INJECTIONS AND AFTER A FEW DAYS THE TECH WENT TO EC AND TREATED WITH IV, STEROIDS, AND MONITORED FOR 4 HOURS UNTIL IT WENT DOWN. SHE WAS PRESCRIBED ORAL PREDNISONE 40MG FOR 5 DAYS. SHE NOW USES DIFFERENT GLOVES." IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, "ONE TECH HAD A SEVERE REACTION ON THE FACE AND HANDS FOR MULTIPLE DAYS AND WAS UNDER THE CARE OF A CLINICIAN BECAUSE HER REACTION WAS SO SEVERE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101432 GLOVE, EXAM, NITRILE, PF, W/ FILM, S LZA MEDLINE INDUSTRIES LP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other