BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INCISION VACUUM PACK

    MDR report key: 3243235 · Received July 19, 2013

    Report

    Report Number
    1920664-2013-00190
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 27, 2013
    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 PRODUCT HAS BEEN REQUESTED FOR EVALUATION; HOWEVER, IT IS NOT AVAILABLE FOR EVALUATION. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING "BAD QUALITY OF THE SLEEVE, DID NOT ENTER BY A 1.8 MM INCISION. THERE WAS NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339138 MICRO INCISION VACUUM PACK HQC BAUSCH & LOMB V0502

    Patients

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