BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGIANCE DISPOSABLE VAGINAL SPECULUM

    MDR report key: 1212051 · Received October 24, 2008

    Report

    Report Number
    MW5008782
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ALLEGIANCE/CARDINAL HEALTH
    Product Code
    HIB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SEVERAL PROVIDERS IN OUR FAMILY MEDICINE CLINIC HAVE REPORTED FAILURES WITH DISPOSABLE VAGINAL SPECULA DURING EXAMINATIONS. THE SPECULA CRACK AND SHATTER DURING EXAMINATIONS. THERE HAVE BEEN APPROX 10 OCCURRENCES OF DEVICE FAILURE OVER THE PAST 45 DAYS. NO INJURIES HAVE BEEN REPORTED THOUGH THE SHATTERED PLASTIC HAS ALMOST STRUCK PROVIDERS IN THE FACE. THE PRIMARY SPECULA INVOLVED APPEAR TO BE ALLEGIANCE DISPOSABLE VAGINAL SPECULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE DISPOSABLE VAGINAL SPECULUM SPECULUM HIB ALLEGIANCE/CARDINAL HEALTH NA
    2 ALLEGIANCE DISPOSABLE VAGINAL SPECULUM SPECULUM HIB ALLEGIANCE/CARDINAL HEALTH
    3 ALLEGIANCE DISPOSABLE VAGINAL SPECULUM SPECULUM HIB ALLEGIANCE/CARDINAL HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1