BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAVES SPECULUM (MED. AND LGE)

    MDR report key: 581685 · Received March 2, 2005

    Report

    Report Number
    MW1034903
    Event Type
    Malfunction
    Date Received
    March 2, 2005
    Date of Event
    March 1, 2005
    Report Date
    March 2, 2005
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    HIB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC HANDLE ON 1 MEDIUM AND 1 LARGE STERILE SPECULUM BROKE OFF IN RPTR'S HAND DURING INSERTION WITH MINIMAL PRESSURE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAVES SPECULUM (MED. AND LGE) STERILE DISPOSABLE SPECULUM HIB SKLAR INSTRUMENTS * 021075
    2 GRAVES SPECULUM (MED.AND LGE) STERILE DISPOSABLE SPECULUM HIB SKLAR INSTRUMENTS * 026190

    Patients

    Seq Age Sex Outcome Treatment
    1 *