BEUDAMED
    FDA Adverse Event Summary report: N

    STERILIZER

    MDR report key: 4122290 · Received September 26, 2014

    Report

    Report Number
    3005899764-2014-00095
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 26, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS MONITORS RELEVANT WEBSITES AND SOCIAL MEDIA SOURCES PER OUR SOCIAL MEDIA POLICY TO IDENTIFY POTENTIAL COMPLAINTS. THROUGH THIS PROCESS, STERIS IDENTIFIED AN ANONYMOUS POST INQUIRING WHAT SHOULD BE DONE IF THERE IS SOMETHING WRONG WITH AN AUTOCLAVE, YET SERVICE PERSONNEL INSTRUCT THE OPERATOR TO CONTINUE THE CYCLE. WE HAVE ATTEMPTED TO CONTACT THE COMPLAINANT AND PROVIDED CONTACT INFORMATION FOR THE STERIS BUSINESS SUPPORT DIRECTOR; HOWEVER, STERIS HAS NOT RECEIVED A RESPONSE. BASED ON THE INFORMATION PROVIDED IN THE ANONYMOUS POST, THIS EVENT APPEARS TO MEET OUR REPORTING CRITERIA FOR MEDICAL DEVICES. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    SOCIAL MEDIA MONITORING IDENTIFIED THE FOLLOWING POST: "IF A TECHNICIAN COMPLAINTS OF AUTOCLAVE MACHINE SOME ERRORS TO SERVICE PERSONNEL, WITHOUT CHECKING AND CORRECTING THE ERROR, SERVICE PERSONNEL ASKED TO CONTINUE THE CYCLE, WHAT SHOULD BE DONE BY THE TECHNICIAN?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600863 STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other