BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1083504 · Received July 29, 2008

    Report

    Report Number
    2084725-2008-00423
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 30, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO REQUESTED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WHO COMPLAINED OF BLISTERING AROUND THEIR MOUTH, LIPS AND A RASH AND MINOR BLISTERS ON THE INSIDE OF THEIR FOREARM WHILE WORKING AROUND A NEWLY INSTALLED UNIT. THE AFFILIATE REPORTED THAT THE CUSTOMER WASHED THEIR HANDS IN BETWEEN LOADS AND THERE WAS NO HANDLING OF INVENTORY THAT DAY. IT IS UNK IF THE CUSTOMER SAW A DR OR REC'D TREATMENT. ADD'L INFO REQUESTED FROM THE AFFILIATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK