BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRADITION SURGICAL GLOVES

    MDR report key: 238417 · Received September 1, 1999

    Report

    Report Number
    1043889-1999-00004
    Event Type
    Malfunction
    Date Received
    September 1, 1999
    Date of Event
    August 6, 1999
    Report Date
    August 16, 1999
    Manufacturer
    MAXXIM MEDICAL, INC./ HONEA PATH FACILITY
    Product Code
    LYY
    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 PROCEDURE. TEARS IN GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRADITION SURGICAL GLOVES LATEX LYY MAXXIM MEDICAL, INC./ HONEA PATH FACILITY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other