BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 1714298 · Received June 3, 2010

    Report

    Report Number
    MW5016249
    Event Type
    Injury
    Date Received
    June 3, 2010
    Date of Event
    May 28, 2010
    Report Date
    June 3, 2010
    Manufacturer
    COVIDIEN/TYCO HEALTHCARE GROUP
    Product Code
    CCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROLONGED PRONE BACK SURGERY RESULTING IN PRESSURE ULCER TO CHIN AND SHEARING/PRESSURE INJURY TO CHEST. DATES OF USE: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: PRONE BACK SURGERY. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN DEVONJACKSON TABLE KIT CHEST PILLOW CCX COVIDIEN/TYCO HEALTHCARE GROUP 31151010 10039K10

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability