BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLS MARTIN L.P.

    MDR report key: 1432389 · Received August 4, 2009

    Report

    Report Number
    MW5012271
    Event Type
    Malfunction
    Date Received
    August 4, 2009
    Date of Event
    August 3, 2009
    Report Date
    August 4, 2009
    Manufacturer
    KLS MARTIN L.P
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER - WOULD NOT SUPPLY A COMPLETE STERILIZATION AND DRY TIME FOR THEIR SURGICAL INSTRUMENTATION. THEY WOULD ONLY SUPPLY THE STERILIZATION TIME, NOT THE DRY TIME THAT IS NECESSARY DURING THE STERILIZATION PROCESS. WITHOUT PROPER & COMPLETE STERILIZATION AND DRY TIME PARAMETERS, VARIOUS INSTITUTIONS COULD BE IMPROPERLY STERILIZING THESE SETS, POTENTIALLY CAUSING INFECTIONS IN PTS. THIS IS UNACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLS MARTIN L.P. LEVEL ONE MODULAR SYS LXH KLS MARTIN L.P

    Patients

    Seq Age Sex Outcome Treatment
    1