BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 810320 · Received January 17, 2007

    Report

    Report Number
    2084725-2007-00010
    Event Type
    Malfunction
    Date Received
    January 17, 2007
    Date of Event
    December 17, 2006
    Report Date
    December 18, 2006
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    k991999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE WORKER COMPLAINED OF BURNING SENSATION AND SKIN DISCOLORATION ON THE HAND UPON REMOVAL OF A BI POUCH PRIOR TO RUNNING A LOAD. THE WORKER DID NOT SEEK MEDICAL ATTENTION AND THE SYMPTOMS RESOLVED WITHIN ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR