BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIS SYSTEM 1

    MDR report key: 513849 · Received March 2, 2004

    Report

    Report Number
    1527821-2004-00002
    Event Type
    Injury
    Date Received
    March 2, 2004
    Date of Event
    September 26, 2001
    Report Date
    February 4, 2004
    Manufacturer
    STERIS CORPORATION, MENTOR HOPKINS
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    STERIS RECEIVED NOTIFICATION OF A LAWSUIT THAT ALLEGES THAT BOTH THE STERIS SYSTEM 1 AND THE STERIS 20 STERILANT ARE DEFECTIVE. THE CORRESPONDENCE CLAIMS THAT THE PLAINTIFF REQUIRED HOSPITAL CARE AT THE TIME OF AN ALLEGED INHALATION INCIDENT AND WILL REQUIRE FUTURE MEDICAL CARE. HOWEVER, THE INFORMATION IS NOT SPECIFIC WITH RESPECT TO THE ALLEGED INCIDENT OR INJURIES. THE ALLEGED DATE OF OCCURRENCE WAS IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 STERILE PROCESSING SYSTEM FLE STERIS CORPORATION, MENTOR HOPKINS UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention