BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM 6 FLUTE BARREL BUR-HOLLOW, FORMULA (5BX)

    MDR report key: 2032663 · Received March 17, 2011

    Report

    Report Number
    2648666-2011-00078
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON BECAME CONCERNED WITH THE HEAT FROM THE SHEATH OF THE UNIT WHICH CAUSED BURNS DURING A DECOMPRESSION. IT WAS FURTHER REPORTED THAT THE UNIT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM 6 FLUTE BARREL BUR-HOLLOW, FORMULA (5BX) BUR HTT STRYKER ENDOSCOPY PUERTO RICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other