BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1231052 · Received October 30, 2008

    Report

    Report Number
    2084725-2008-00712
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    April 1, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-0848-2008, 2084725-09/
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: OTHER - THIS ISSUE HAS BEEN ADDRESSED THROUGH CORRECTION & REMOVAL, WHERE THE USER GUIDE WAS UPDATED BASED ON USER REPORTS ABOUT CONTACT WITH RESIDUAL HYDROGEN PEROXIDE FROM INSTRUMENTS POUCHES, AND TRAYS AFTER STERILIZATION, AND SUBSEQUENT LIGHT COLORED RESIDUE ON THESE DEVICES AFTER STERILIZATION.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT A CUSTOMER WHO REPORTED THAT "SOMETIMES THE LOAD WAS WET AFTER STERILIZATION." THE CUSTOMER ALLEGED THAT SHE/HE DID NOT CONTACT H2O2 DIRECTLY HOWEVER, EXPERIENCED REDNESS AROUND THE EYES AND REPORTED TO HAVE MORE EYE MUCUS THAN BEFORE. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION, BUT APPLIED GENTIMICIN. THE AFFILIATE REPORTED THAT THE LOAD AND CUSTOMER'S PRE-CLEANING PROCEDURES WERE UNK. THE CUSTOMER WAS NOT WEARING A PROTECTIVE GEAR. THE UNIT WAS SERVICED ON 22ND SEPT 2008. IT WAS A PLANNED MAINTENANCE, AND THERE WAS NOTHING WRONG FOUND. THE CUSTOMER'S SKIN RASH HAS RESOLVED.

    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