BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOE, EXAM, ULTRA, VINYL, PF, MEDI

    MDR report key: 293496 · Received August 28, 2000

    Report

    Report Number
    9680130-2000-00001
    Event Type
    Malfunction
    Date Received
    August 28, 2000
    Date of Event
    July 24, 2000
    Report Date
    August 23, 2000
    Manufacturer
    SHANGHAI PT PLASTICS ENTERPRISE CO.
    Product Code
    LYZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE USER WAS EXPOSED TO BLOOD DUE TO A PINHOLE IN THE FINGERTIP OF THE GLOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOE, EXAM, ULTRA, VINYL, PF, MEDI PATIENT EXAMINATION GLOVE LYZ SHANGHAI PT PLASTICS ENTERPRISE CO. MDS193075 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other