BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL TROCAR HANDLE, NO CANNULA

    MDR report key: 2051295 · Received April 6, 2011

    Report

    Report Number
    8010177-2011-00103
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    MINOR TEAR OF SOFT TISSUE BY SURGEON/RESIDENT WHILE ATTEMPTING TO ATTACH CHEEK RETRACTOR TO THE TROCAR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL TROCAR HANDLE, NO CANNULA INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR