BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRIT SELECT

    MDR report key: 5212525 · Received November 9, 2015

    Report

    Report Number
    3006433555-2015-00411
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 15, 2015
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS WHICH DETERMINED THERE WAS NO DEFECT FOUND WITH THE BED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE BED EXIT WAS SET A PATIENT ALLEGEDLY FELL FROM THE BED SUSTAINING A SKIN TEAR ON FOREHEAD AND POSSIBLE CONTUSION. MEDICAL INTERVENTION WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE BED EXIT WAS SET A PATIENT ALLEGEDLY FELL FROM THE BED SUSTAINING A SKIN TEAR ON FOREHEAD AND POSSIBLE CONTUSION. MEDICAL INTERVENTION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743167 SPIRIT SELECT BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS

    Patients

    Seq Age Sex Outcome Treatment
    1