BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INCISION VACUUM PACK

    MDR report key: 2193263 · Received July 13, 2011

    Report

    Report Number
    1920664-2011-00086
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BAUSCH & LOMB, INC.
    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 SURVEILLANCE AND LOT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER PROVIDED BY THE CUSTOMER IS INVALID. A RECORD REVIEW WILL BE CONDUCTED IF A VALID LOT NUMBER IS PROVIDED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM FRANCE STATING "IMPOSSIBLE TO INSERT IN THE INCISION. NO PT IMPACT." ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO INCISION VACUUM PACK HQC BAUSCH & LOMB, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLARIS EQUIPMENT (BAUSCH & LOMB)