BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACTION BUR GUARD

    MDR report key: 2200776 · Received July 28, 2011

    Report

    Report Number
    1811755-2011-02690
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K961970
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPIRATION DATE OF THE DEVICE WAS NOT PROVIDED; WITHOUT IT IS NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE. ACCORDING TO THE USER FACILITY, THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THERE IS NO RECORD OF THE IMPACTION BUR GUARD BEING RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPACTION BURR GUARD MELTED AND BURNED A (B)(6) OLD, FEMALE, PATIENT ON THE RIGHT UPPER LIP. THE BURN WAS A 1CM SECOND DEGREE BURN. NO SCARING IS EXPECTED. A TOPICAL TREATMENT WAS APPLIED. AN ALTERNATE DRILL WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION BUR GUARD HWE STRYKER INSTRUMENTS KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other CORE IMPACTION DRILL