BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELIGARD

    MDR report key: 1852962 · Received September 29, 2010

    Report

    Report Number
    MW5017655
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    TOLMAR, INC. DISTRIBUTED BY SANOFI AVENTIS
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ELIGARD 45 MG - NDC 00024-0605-45 LOT #3865 PRODUCT COMES IN 2 SYRINGES THAT MUST BE CONSTITUTED BEFORE USE. THE SYRINGE THAT CONTAINS THE ACTIVE DRUG IN POWDER FORM, IS CRYSTALIZING. WE HAVE HAD 3 REPORTS IN 2 DAYS OF THE PROBLEM. DOSE OR AMOUNT: 45 MG. ROUTE: SQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELIGARD LEUPROLIDE ACETATE LRP TOLMAR, INC. DISTRIBUTED BY SANOFI AVENTIS 3865

    Patients

    Seq Age Sex Outcome Treatment
    1