BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO INCISION VACUUM PACK

    MDR report key: 3204781 · Received July 1, 2013

    Report

    Report Number
    1920664-2013-00165
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Adverse Event
    Yes
    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. THIS REPORT IS RELATED TO THE EVENT REPORTED ON MDR 1920664-2013-001163, 164, 166, 167, 168, 169.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM FRANCE STATING "BAD QUALITY OF THE SLEEVE, THEY ARE TOO SOFT, NOT RIGID ENOUGH, DID NOT ENTER BY A 1.8 MM INCISION. THERE WAS NO PATIENT INJURY". ADDITIONAL INFORMATION RECEIVED STATES THERE HAVE BEEN APPROXIMATELY SEVEN INCISION ENLARGEMENTS DUE TO THIS ISSUE. THE EXACT NUMBER IS UNKNOWN. THOUGH REQUESTED THE FACILITY HAS NOT PROVIDED BY SPECIFIC INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297597 MICRO INCISION VACUUM PACK HQC BAUSCH & LOMB U9906

    Patients

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