BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE

    MDR report key: 1662695 · Received April 12, 2010

    Report

    Report Number
    2937137-2010-00004
    Event Type
    Injury
    Date Received
    April 12, 2010
    Date of Event
    November 23, 2008
    Report Date
    April 11, 2010
    Manufacturer
    SUNRISE MEDICAL, INC
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS UNAVAILABLE TO MFR FOR EVAL. NO INFO AS TO WHAT MAY HAVE CAUSED THE PRESSURE SORES OTHER THAN USE OF CHAIR AT TIME USER REC'D CHAIR AND PRIOR TO RECEIVING CHAIR. NOT ENOUGH INFO FROM ATTORNEY TO EVALUATE EXISTING PRODUCT IN HOUSE.

    Description of Event or Problem · 1

    REPORTER STATES USER DEVELOPED A SEVERE PRESSURE SORE ON HIS BACK AND EXACERBATED EXISTING PRESSURE SORES THAT HE HAD ON HIS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE WHEELCHAIR, POWERED ITI SUNRISE MEDICAL, INC QUICKIE S646 EIS62

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other