BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA SURGICAL GLOVES

    MDR report key: 234344 · Received August 2, 1999

    Report

    Report Number
    1043889-1999-00003
    Event Type
    Malfunction
    Date Received
    August 2, 1999
    Date of Event
    July 6, 1999
    Report Date
    July 26, 1999
    Manufacturer
    MAXXIM MEDICAL, INC. HONEA PATH FACILITY
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PINHOLES LEAVING BLOOD ON HANDS AFTER PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA SURGICAL GLOVES LATEX KGO MAXXIM MEDICAL, INC. HONEA PATH FACILITY NA 49036J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other