BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN

    MDR report key: 302528 · Received October 30, 2000

    Report

    Report Number
    1618732-2000-00119
    Event Type
    Other
    Date Received
    October 30, 2000
    Date of Event
    September 26, 2000
    Report Date
    October 30, 2000
    Manufacturer
    JOHNSON & JOHNSON MEDICAL INC
    Product Code
    FYA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS AN EMPLOYEE SUFFERED ANAPHYLACTIC REACTION REQUIRING I.V. MEDICATION AFTER WEARING THE GOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R