BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRIER EXTRA PROTECTION SURGICAL GOWN, EXTRA

    MDR report key: 174592 · Received June 26, 1998

    Report

    Report Number
    1618732-1998-00150
    Event Type
    Malfunction
    Date Received
    June 26, 1998
    Report Date
    May 28, 1998
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC.
    Product Code
    FYA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 7/2/1998 H2: BASED UPON THE FDA RESPONSE LETTER, DATED 6/5/1997, THIS COMPLAINT IS REPORTABLE TO THE FDA SINCE IT IS "A DEVICE LABELED TO BE IMPERVIOUS TO FLUID PENETRATION AND WOULD BE CONSIDERED A MALFUNCTION THAT IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR." H3: THERE WAS NO SAMPLE RETURNED NOR LOT NUMBER PROVIDED. THE EVALUATION OF THIS REPORTED EVENT WAS LIMITED DUE TO AMOUNT OF INFO AVAILABLE. A REVIEW OF COMPLAINT TRENDS DOES NOT INDICATE THAT THERE HAS BEEN A RECENT INCREASE IN THE NUMBER OF STRIKETHROUGH COMPLAINTS. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    ACCOUNT CONTACT REPORTS: STRIKETHROUGH HAD OCCURRED AT THIS FACILITY WITH AN IMPERVIOUS GOWN. OVER THE LAST MONTH, OPERATING ROOM TECHNICIAN NOTED MULTIPLE OCCURRENCES WHERE DRIED BLOOD SPOTS WERE ON SCRUBS. AFTER ONE CASE, FOREARMS WERE COVERED WITH DRIED BLOOD FROM A PT KNOWN TO HAVE HEPATITIS. THERE WAS NO TREATMENT RENDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRIER EXTRA PROTECTION SURGICAL GOWN, EXTRA GOWN, SURGICAL FYA JOHNSON & JOHNSON MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other