BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INCISION VACUUM PACK

    MDR report key: 4223649 · Received August 5, 2014

    Report

    Report Number
    1920664-2014-00165
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS DISCARDED THE PRODUCT, IT IS NOT AVAILABLE FOR EVALUATION. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.

    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
    456348 MICRO INCISION VACUUM PACK STELLARIS ANTERIOR SYSTEM HQC BAUSCH & LOMB BL5113 V2520

    Patients

    Seq Age Sex Outcome Treatment
    1