BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOWN,ISO,THUMBLOOP,POLYETHYLENE,BLUE,REG

    MDR report key: 10501328 · Received September 8, 2020

    Report

    Report Number
    1417592-2020-00084
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    August 8, 2020
    Report Date
    September 15, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTING FACILITY RETURNED UNUSED SAMPLES TO THE MANUFACTURER FOR EVALUATION. THE RETURNED SAMPLES WERE FOUND TO MEET PRODUCT SPECIFICATIONS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE INITIALLY REPORTED PRODUCT LOT NUMBER AND NO NON-CONFORMANCES WERE IDENTIFIED. THERE WERE NO CHANGES TO THE MANUFACTURING PROCESS AND NO NATURAL RUBBER LATEX WAS UTILIZED DURING THE MANUFACTURE OF THE REPORTED PRODUCT LOT NUMBER. A ROOT CAUSE FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE ANOTHER SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A CLINICIAN EXPERIENCED AN ALLERGIC REACTION DURING USE OF THE ISOLATION GOWN. REPORTEDLY, AFTER APPROXIMATELY 20-30 MINUTES OF USE, THE CLINICIAN EXPERIENCED "DIFFUSE HIVES, ITCHING, PERIPHERAL EDEMA (HANDS), SOME DIFFICULTY SWALLOWING, ANXIOUS, HEADACHE, NAUSEA AND DIZZINESS." AFTER THE INCIDENT, THE CLINICIAN WENT TO AN URGENT CARE CENTER AND WAS MEDICATED WITH SOLU-CORTEF 125MG IM, PREDNISONE TAPER, FOUR (4) DOSES BENADRYL 50MG, AND THREE (3) DOSES PEPCID 40MG. THE CLINICIAN WAS DISCHARGED HOME TO FOLLOW-UP WITH HIS PHYSICIAN. NO DIAGNOSTIC TESTING OR ADDITIONAL MEDICAL TREATMENT WAS REPORTED TO THE MANUFACTURER. NO IMPACT TO A PATIENT WAS REPORTED TO THE MANUFACTURER. DUE TO THE REPORTED NEED FOR MEDICAL TREATMENT, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLINICIAN EXPERIENCED AN ALLERGIC REACTION DURING USE OF THE ISOLATION GOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966916 GOWN,ISO,THUMBLOOP,POLYETHYLENE,BLUE,REG OEA MEDLINE INDUSTRIES INC. 36219090083

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention