BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLV EXAM NITRILE ESTEEM COMFORT LG

    MDR report key: 11323849 · Received February 12, 2021

    Report

    Report Number
    1423537-2021-00594
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    January 19, 2021
    Report Date
    March 4, 2021
    Manufacturer
    SGP01 SINGAPORE
    Product Code
    LZC
    UDI-DI
    02088538016941
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE ON THE ORIGINAL SUBMISSION THE PRODUCT CODE LCZ WAS USED IN ERROR. THE CORRECT PRODUCT CODE IS LZC. AT THE TIME OF INVESTIGATION, NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. WITHOUT THE LOT NUMBER, WE ARE UNABLE TO TRACE THE MANUFACTURER OR REVIEW THE DEVICE HISTORY RECORDS FOR FURTHER INVESTIGATION. NO SAMPLE WAS PROVIDED AT THE TIME OF THIS INVESTIGATION. BASED ON INVESTIGATION THE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO NO LOT NUMBER OR SAMPLE BEING PROVIDED. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME, DUE TO ROOT CAUSE NOT BEING IDENTIFIED. WE WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF INVESTIGATION, NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. WITHOUT THE LOT NUMBER, WE ARE UNABLE TO TRACE THE MANUFACTURER OR REVIEW THE DEVICE HISTORY RECORDS FOR FURTHER INVESTIGATION. NO SAMPLE WAS PROVIDED AT THE TIME OF THIS INVESTIGATION. BASED ON INVESTIGATION THE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO NO LOT NUMBER OR SAMPLE BEING PROVIDED. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME, DUE TO ROOT CAUSE NOT BEING IDENTIFIED. WE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    BASED ON INFORMATION RECEIVED FROM THE END-USER, SHE REPORTEDLY HAD HAND AND ARM SWELLING, INFLAMMATION, FACIAL SWELLING, FULL BODY ITCHING. REPORTEDLY SHE HAS SEEN DOCTORS SEVERAL TIMES. THE (B)(6) CLINIC DERMATOLOGIST IN (B)(6) IS CALLING THIS A TYPE 4 ALLERGY. SHE REPORTEDLY HAD PATCH TESTING DONE WHICH SHOWS ALLERGIC TO A RUBBER PRODUCT. SHE WAS ADVISED TO USE SKIN LOTION AND VANICREAM AND HAS BEEN GIVEN A STEROID FOR SEVERE SWELLINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221558 GLV EXAM NITRILE ESTEEM COMFORT LG PATIENT EXAMINATION GLOVE, SPECIALTY LZC SGP01 SINGAPORE 88ES04L UNKNOWN 02088538016941

    Patients

    Seq Age Sex Outcome Treatment
    1 Other