BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZATION SYSTEM

    MDR report key: 1032733 · Received April 22, 2008

    Report

    Report Number
    2084725-2008-00133
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WHO EXPERIENCED A HYDROGEN PEROXIDE "BURN" ON HIS THUMB. THE CUSTOMER REPORTED THAT HE FELT HIS THUMB START TO "TINGLE" AFTER HE REMOVED A "SUCCESSFUL LOAD" FROM THE UNIT, SO HE WIPED IT WITH AN ALCOHOL WIPE. THE CUSTOMER RAN HIS HAND UNDER COLD TAP WATER FOR A "LONG PERIOD". THE CUSTOMER SAW HIS DOCTOR BUT DID NOT RECEIVE TREATMENT FOR THE CONTACT. THE ASP INTERNATIONAL 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 NX STERILIZATION SYSTEM STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10033 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STERRAD NX CASSETTES