BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 1882338 · Received October 22, 2010

    Report

    Report Number
    1525712-2010-00157
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 22, 2010
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESIDENT WAS BACKING UP TO THE BED WHEN THEIR LEG IMPACTED THE RAIL RESULTING IN A PUNCTURE WOUND. NO STITCHES WERE REQUIRED; THE MEDICAL FACILITY WAS USING A WOUND VAC TO TREAT THE WOUND. A TECHNICIAN WENT OUT TO ASSESS THE BED. THE TECHNICIAN DID NOT SEE ANY NEED TO BRING THE PRODUCT BACK. PER HIS REPORT, THE ASSIST RAILS DID NOT HAVE ANY MANUFACTURING FLAWS OR DAMAGE AND THERE WEREN'T ANY PROTRUDING EDGES. THE FACILITY WAS TRAINED ON THE PROPER METHOD TO USE THE EQUIPMENT. MDR FILED BASED ON ALLEGED WOUND TREATMENT.

    Additional Manufacturer Narrative · 1

    THE RESIDENT WAS BACKING UP TO THE BED WHEN THEIR LEG IMPACTED THE RAIL RESULTING IN A PUNCTURE WOUND. NO STITCHES WERE REQUIRED THE MEDICAL FACILITY WAS USING A WOUND VAC TO TREAT THE WOUND. A TECHNICIAN WENT OUT TO ASSESS THE BED. THE TECHNICIAN DID NOT SEE ANY NEED TO BRING THE PRODUCT BACK. PER HIS REPORT, THE ASSIST RAILS DID NOT HAVE ANY MANUFACTURING FLAWS OR DAMAGE AND THERE WEREN'T ANY PROTRUDING EDGES. THE FACILITY WAS TRAINED ON THE PROPER METHOD TO USE THE EQUIPMENT. MDR FILED BASED ON ALLEGED WOUND TREATMENT.

    Description of Event or Problem · 1

    THE RAIL WAS IN THE DOWN POSITION AND WHEN THE CONSUMER BACKED UP TO THE BED TO SIT DOWN, THE CONSUMER'S LEG ALLEGEDLY WAS PUNCTURED BY THE LITTLE BLACK PEG ON THE RAIL. SERIOUS INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE RAIL WAS IN THE DOWN POSITION AND WHEN THE CONSUMER BACKED UP TO THE BED TO SIT DOWN, THE CONSUMER'S LEG ALLEGEDLY WAS PUNCTURED BY THE LITTLE BLACK PEG ON THE RAIL. SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 ITI INVACARE CS7

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention