BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYETHYLENE ISOLATION GOWNS WITH THUMB LOOP

    MDR report key: 10493557 · Received September 4, 2020

    Report

    Report Number
    10493557
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 8, 2020
    Report Date
    August 25, 2020
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    ONE OF OUR NURSES WAS ATTENDING TO A PATIENT AND HAD A SIGNIFICANT ANAPHYLACTIC REACTION TO WHAT HE BELIEVES TO BE A GOWN HE WAS WEARING AS PPE. THE GOWN WAS SOURCED THROUGH MEDLINE AND OF COURSE HAS A DISCLAIMER ON THE BOX INDICATING THAT THE GOWNS WERE LATEX FREE. THE NURSE IS ALLERGIC TO LATEX. WE PULLED ALL THE REMAINING STOCK FROM ALL OF OUR UNITS AND OFFICES AND MADE MEDLINE AWARE OF THE EVENT. WE TRIED TO REACH A MEDICAL DIRECTOR BUT MEDLINE CLAIMS TO NOT HAVE ONE. THEY HAVE ASSURED US THEY ARE LOOKING INTO THE SITUATION.

    Description of Event or Problem · 1

    ONE OF OUR NURSES WAS ATTENDING TO A PATIENT AND HAD A SIGNIFICANT ANAPHYLACTIC REACTION TO WHAT HE BELIEVES TO BE A GOWN HE WAS WEARING AS PPE. THE GOWN WAS SOURCED THROUGH MEDLINE AND OF COURSE HAS A DISCLAIMER ON THE BOX INDICATING THAT THE GOWNS WERE LATEX FREE. THE NURSE IS ALLERGIC TO LATEX. WE PULLED ALL THE REMAINING STOCK FROM ALL OF OUR UNITS AND OFFICES AND MADE MEDLINE AWARE OF THE EVENT. WE TRIED TO REACH A MEDICAL DIRECTOR BUT MEDLINE CLAIMS TO NOT HAVE ONE. THEY HAVE ASSURED US THEY ARE LOOKING INTO THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958517 POLYETHYLENE ISOLATION GOWNS WITH THUMB LOOP NON-SURGICAL ISOLATION GOWN OEA MEDLINE INDUSTRIES, INC. CRI5000 30080196749618

    Patients

    Seq Age Sex Outcome Treatment
    1 18615 DA Other