BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 263264 · Received February 14, 2000

    Report

    Report Number
    MW1018147
    Event Type
    Malfunction
    Date Received
    February 14, 2000
    Report Date
    January 11, 2000
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC.
    Product Code
    HIS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PRODUCT CAUSES PAIN, FREQUENTLY BURSTS/TEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CONDOM, LATEX, LUBRICATED HIS ANSELL HEALTHCARE PRODUCTS, INC. * 0806254200
    2 * CONDOM, LATEX, LUBRICATED HIS ANSELL HEALTHCARE PRODUCTS * 0812923224

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other