BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE STANDARD GOWN

    MDR report key: 149968 · Received October 21, 1997

    Report

    Report Number
    MW4002130
    Event Type
    Malfunction
    Date Received
    October 21, 1997
    Report Date
    October 21, 1997
    Manufacturer
    STERILE RECOVERIES, INC.
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR, A VASCULAR SURGEON, ALLEGED THAT THE REUSABLE STANDARD GOWNS ARE UNSAFE FOR USE IN SURGICAL OPERATIONS IN THAT BLOOD AND FLUIDS FROM A PT CAN STRIKE THROUGH THE GOWN. HE AND HIS COLLEAGUES IN HOSPS HAVE EXPERIENCED THE STRIKE THROUGH INCIDENTS DURING OPERATIONS. THIS WOULD EXPOSE ANY HEALTHCARE PROVIDERS TO POTENTIAL RISKS LIKE AIDS AND HEPATITIS. DR WANTS TO KNOW WHY THIS UNSAFE SURGICAL GOWN WAS APPROVED BY THE FDA FOR USE IN SURGICAL OPERATIONS. ON 10/23/97, FIELD OFFICER MET WITH THE COMPLAINANT FACILITIES RISK MGR & OR MGR. ACCORDING TO OR MGR, THE HOSP SWITCHED TO THE RESUSABLE SURGICAL GOWNS FROM THE DISPOSABLE ONES IN 10/97. THERE WERE TWO TYPES OF REUSABLE SURGICAL GOWNS OFFERED BY STERILE RECOVERIES, INC TO THIS HOSP. THE STANDARD SURGICAL GOWNS (LIQUID RESISTANT) AND THE LIQUIDPROOF GOWNS. THE COMPLAINT INVESTIGATION DETERMINED THAT THE HOSP SHOULD HAVE ASSIGNED THE LIQUIDPROOF GOWN TO THE COMPLAINANT FOR A VASCULAR SURGERY. FIELD OFFICER TOLD RISK MGR THE HOSP SHOULD CHOOSE THE CORRECT TYPE OF SURGICAL GOWN FOR EMPLOYEES TO USE FOR SURGICAL OPERATIONS. DURING THE INSPECTION AT SRI, FIELD OFFICER WAS TOLD BY SRI GENERAL MANAGER THAT THE HOSP HAS STOPPED USING THE STANDARD SURGICAL GOWNS FOR OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE STANDARD GOWN REUSABLE STERILE STANDARD GOWN FYA STERILE RECOVERIES, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA