BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRIER N-95 PARTICULATE RESPIRATOR

    MDR report key: 102057 · Received July 2, 1997

    Report

    Report Number
    1618732-1997-00143
    Event Type
    Injury
    Date Received
    July 2, 1997
    Report Date
    July 1, 1997
    Manufacturer
    LOUIS M. GERSON
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONTACT REPORTS THAT THEY HAVE HAD 5 TUBERCULOSIS PPD/SKIN TEST CONVERSATIONS FOR NURSING PERSONNEL IN SEVERAL AREAS. THREE OF FIVE CONVERSIONS RELATED TO ONE TB PT. PERSONNEL HAD TO START INH PROPHYLAXIS MEDS FOR TB EXPOSURE/INFECTION. THESE CONVERSIONS WERE IDENTIFIED AFTER CHANGING TO A DIFFERENT TB RESPIRATOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARRIER N-95 PARTICULATE RESPIRATOR MASK, SURGICAL FXX LOUIS M. GERSON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention