BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1702010 · Received May 17, 2010

    Report

    Report Number
    1702010
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Date of Event
    May 14, 2010
    Report Date
    May 17, 2010
    Manufacturer
    SANOFI-AVENTIS U.S. LLC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    HYALGAN INJECTION INTO LEFT KNEE. DURING INJECTION, THE GLASS PREFILLED SYRINGE FAILED AND THE GLASS BLEW OUT OF THE SIDE. NO ONE WAS INJURED AND THE NEEDLE WAS KEPT IN PLACE. A NEW SYRINGE WAS USED WITH HYALGAN INJECTED WITHOUT DIFFICULTY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================PHYSICIAN STATED THE ASPIRATION WAS FINE BUT AS SOON AS HE APPLIED PRESSURE TO BEGIN THE INJECTION, THE GLASS BROKE. IT DID NOT COME OFF THE HUB, BUT BROKE ON THE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HYALGAN PREFILLED SYRINGE FMF SANOFI-AVENTIS U.S. LLC 50084283 128400

    Patients

    Seq Age Sex Outcome Treatment
    1 *