BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN

    MDR report key: 164188 · Received April 24, 1998

    Report

    Report Number
    1618732-1998-00071
    Event Type
    Other
    Date Received
    April 24, 1998
    Report Date
    February 24, 1998
    Manufacturer
    JOHNSON & JOHNSON MEDICAL
    Product Code
    FYA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS AN EMPLOYEE DEVELOPED EITHER A FUNGAL OR CONTACT DERMATITIS TYPE RASH ON THE ARMS WHILE WEARING THE GOWN. THEY STATED THAT "THE RASH DID DEVELOP INTO BLISTERS THAT WERE FROM PIN HEAD SIZE TO ERASER SIZE". THEY STATED THAT THE EMPLOYEE DID RECEIVE MEDICAL ATTENTION RECEIVING TREATMENT WITH BENADRYL CREAM, STEROID CREAM, AND STEROID PACKS. RASH BECOMES BETTER WHEN NOT WEARING THE GOWN. THEY REPORTED NO PERMANENT DAMAGE IMPAIRMENT TO THE AFFECTED AREA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R