BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1060225 · Received June 12, 2008

    Report

    Report Number
    2084725-2008-00265
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. SVC FOUND THE UNIT TO BE WORKING TO SPECIFICATIONS, THE VAPORIZER PLATE WAS IN PLACE.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WHO EXPERIENCED A "BURN" ON THEIR FINGERS. THE CUSTOMER REPORTED THAT THE CONTACT SITE HAD WHITE DISCOLORATION AND A BURNING SENSATION. THE CUSTOMER RAN THE SITE UNDER RUNNING, SAW A DOCTOR, AND WAS PRESCRIBED GENTAMICIN OINTMENT. THE AFFILIATE SENT FIELD SVC TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK