BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 50 STERILIZATION SYSTEM

    MDR report key: 1051445 · Received May 21, 2008

    Report

    Report Number
    2084725-2008-00180
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K981625
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, SKIN CONTACT WITH HYDROGEN PEROXIDE. CAPITAL EQUIPMENT, FSE WENT TO THE FACILITY. THE FSE CHECKED THE CASSETTE AND DID NOT FIND A PROBLEM. HE ALSO FOUND THE UNIT WORKING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WHO STATED THAT AN EMPLOYEE RECEIVED A "BURN" ON THEIR LEFT INDEX AND MIDDLE FINGERS FROM HANDLING A CASSETTE THAT WAS EJECTED FROM THE UNIT. THE HEALTHCARE WORKER REPORTED PAIN AND WHITE DISCOLORATION AT THE CONTACT SITE. THE HEALTHCARE WORKER RINSED THE CONTACT SITE UNDER RUNNING WATER AND DID NOT SEE A DOCTOR OR RECEIVE TREATMENT. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 50 STERILIZATION SYSTEM STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CATALOG # 10115| LOT# 07J001| STERRAD 50 CASSETTE