BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSUREPLUS POUCHES

    MDR report key: 3823638 · Received February 28, 2014

    Report

    Report Number
    2219682-2014-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Report Date
    January 31, 2014
    Manufacturer
    DSHEALTHCARE INC.
    Product Code
    KCT
    PMA / PMN Number
    K953829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR CONTAMINATION EXISTS IF NOT DISCOVERED BY THE CLINICIAN. THEREFORE, BECAUSE THE CONSEQUENCES OF THIS MALFUNCTION AFFECT THE DEVICE IN A MANNER THAT MAY LEAD TO A DEATH, SERIOUS INJURY/ILLNESS OR REQUIRE INTERVENTION TO PRECLUDE SUCH, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE CUSTOMER RETURNED A BOX WITH UNUSED POUCHES. THE POUCHES WERE TESTED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS EVENT IS WAS REPORTED THAT ASSURE PLUS POUCHES WERE SPILLING DURING THE STERILIZATION PROCESS; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124028 ASSUREPLUS POUCHES STERILIZATION WRAP KCT DSHEALTHCARE INC. 5846232711

    Patients

    Seq Age Sex Outcome Treatment
    1