BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO INCISION VACUUM PACK

    MDR report key: 2992363 · Received March 1, 2013

    Report

    Report Number
    1920664-2013-00036
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 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. REPORT 2 OF 2.

    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." ADDITIONAL INFORMATION RECEIVED STATES THERE HAVE BEEN INCISION ENLARGEMENTS DUE TO THIS ISSUE. THOUGH REQUESTED THE FACILITY HAS NOT PROVIDED ANY SPECIFIC INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89915 MICRO INCISION VACUUM PACK HQC BAUSCH & LOMB U9277

    Patients

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