BEUDAMED
    FDA Adverse Event Death Summary report: N

    WHEELCHAIR

    MDR report key: 2689028 · Received August 3, 2011

    Report

    Report Number
    1417592-2012-00065
    Event Type
    Death
    Date Received
    August 3, 2011
    Date of Event
    March 17, 2012
    Report Date
    August 2, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAUGHTER RECEIVED A REPORT FROM THE NURSING HOME THAT HER MOTHER WAS PLACED IN THE WHEELCHAIR IN HER ROOM BY THE DOORWAY FACING INTO THE HALL. SHE WAS MEDICATED FOR DEMENTIA AND ALZHEIMER'S DISEASE. SHE WAS RECOVERING FROM A SURGICAL REPAIR OF A LEG FRACTURE AND WAS ON ANTICOAGULANTS. SHE HAD NEUROPATHY OF HER FEET. SHE WAS RESTRAINED AND LEFT UNATTENDED WHILE SITTING IN THE CHAIR. SHE APPARENTLY FELL FORWARD WITH THE CHAIR AND WAS FOUND FACE DOWN. SHE WAS ADMITTED TO THE HOSPITAL WITH FACIAL AND HEAD TRAUMA. SHE DIED THE FOLLOWING DAY. THE DAUGHTER STATES IT WAS SPECULATED THAT POSSIBLY THE WHEEL OF THE CHAIR BECAME CAUGHT IN THE DOOR JAM AND WHILE TRYING TO CORRECT IT, THE END USER FELL FORWARD. THE NURSING HOME DID NOT CONFIRM THE CAUSE OF THE INCIDENT AND IT WAS DEEMED TO BE AN ACCIDENTAL DEATH. THE DAUGHTER HAS WORKED WITH THE NURSING HOME AND THEY HAVE NOT BEEN ABLE TO LOCATE THE CHAIR FOR EVALUATION. THERE HAS BEEN NO INFORMATION INDICATING THE CHAIR DID NOT PERFORM AS INTENDED AND IT IS NOT BELIEVED THAT THE CHAIR CAUSED THE INCIDENT. THE DAUGHTER STATES SHE DID NOT SEE ANY VISIBLE DAMAGE TO THE CHAIR FOLLOWING THE INCIDENT. WE HAVE NO PHOTOS TO EVALUATE AND CANNOT CONFIRM SHE WAS ACTUALLY SITTING IN THE MEDLINE CHAIR AT THE TIME OF THE INCIDENT. A ROOT CAUSE HAS NOT BEEN DETERMINED. HOWEVER, DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER WAS LEFT UNATTENDED WHILE SITTING RESTRAINED IN THE WHEELCHAIR. SHE APPARENTLY FELL FORWARD WITH THE CHAIR AND WAS FOUND FACE DOWN. SHE WAS ADMITTED TO THE HOSPITAL WITH FACE AND HEAD TRAUMA. SHE SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR IOR MEDLINE INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| H