BEUDAMED
    FDA Adverse Event Summary report: N

    FORMULA

    MDR report key: 3940506 · Received June 12, 2014

    Report

    Report Number
    3940506
    Date Received
    June 12, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HTT
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE DEVICE WAS BEING USED THE PORT WAS AT 60 DEGREES AND CAME IN CONTACT WITH THE PATIENT'S SKIN AND CAUSED A SUPERFICIAL BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347299 FORMULA BUR, SURGICAL HTT STRYKER ENDOSCOPY 375-562-000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR