BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2041938 · Received March 29, 2011

    Report

    Report Number
    1525712-2011-00140
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 16, 2009
    Report Date
    March 29, 2011
    Manufacturer
    INVACARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER ALLEGEDLY THEIR BED COLLAPSED AND REQUIRED ADD'L SURGERY. PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE OR A SET UP ERROR MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION. MALFUNCTION IS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE CONSUMER WAS LYING IN BED AND LOWERING THE BED WHEN THE BED ALLEGEDLY COLLAPSED, CAUSING HIM TO RE-INJURE HIS BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE PMI5000 BED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention