BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INCISION VACUUM PACK

    MDR report key: 4223638 · Received August 5, 2014

    Report

    Report Number
    1920664-2014-00163
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS DISCARDED THE PRODUCT, IT IS NOT AVAILABLE FOR EVALUATION. UNABLE TO REVIEW STERILIZATION AND LOT HISTORY RECORDS SINCE THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(6) STATING: "STABLE CHAMBER CLOGGED. NO PATIENT IMPACT, NO PRODUCT RETURNED, THE CASSETTE WAS CHANGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458403 MICRO INCISION VACUUM PACK STELLARIS ANTERIOR SYSTEM HQC BAUSCH & LOMB BL5113

    Patients

    Seq Age Sex Outcome Treatment
    1