BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOWN, SURGICAL L2

    MDR report key: 9666001 · Received February 4, 2020

    Report

    Report Number
    1000306225-2020-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 14, 2020
    Report Date
    January 30, 2020
    Manufacturer
    NOVO HEALTH SERVICES, LLC
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, THE END-USER REPORTED A STRIKETHROUGH WHILE WEARING A LEVEL II SURGICAL GOWN DURING A ORTHOPEDIC HIP SURGERY. THE GOWN WAS NOT SENT BACK TO THE FACILITY FOR TESTING. 1. AWARENESS DOCUMENTED TRAINING WAS PROVIDED TO THE EMPLOYEES. 2. HISTORICAL REVIEW OF TITRATION REPORTS, NO QUALITY EXCEPTIONS WERE RECORDED. 3. REVIEW OF THE PRODUCT THAT THE CUSTOMER ORDERS AND DISCUSSION ON BARRIER LEVELS. 6. REVIEW OUR PROCESSES AND PROCEDURES; NO UPDATES NEEDED. THE ROOT CAUSE FOR THE REPORTED ISSUE IS WEARING THE WRONG BARRIER LEVEL PRODUCT FOR A ORTHOPEDIC HIP PROCEDURE. THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2020 THE END-USER REPORTED A STRIKETHROUGH WEARING A LEVEL II REUSABLE SURGICAL GOWN DURING A ORTHOPEDIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130920 GOWN, SURGICAL L2 REUSABLE SURGICAL GOWN FYA NOVO HEALTH SERVICES, LLC 700*

    Patients

    Seq Age Sex Outcome Treatment
    1 Other