BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRIER EXTRA PROTECTION SURGICAL GOWN, LARGE

    MDR report key: 174587 · Received June 26, 1998

    Report

    Report Number
    1618732-1998-00152
    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
    Adverse Event
    Yes
    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. ONE PHYSICIAN NOTED DRIED BLOOD ON FOREARMS AFTER AN OPERATING ROOM CASE ON A PT WHO WAS POSITIVE FOR HEPATITIS. THERE WAS NO TREATMENT RENDERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other