BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATTRESS COVER FOR MEDICAL PURPOSES

    MDR report key: 2180063 · Received July 27, 2011

    Report

    Report Number
    1525712-2011-00373
    Event Type
    Death
    Date Received
    July 27, 2011
    Date of Event
    December 31, 2007
    Report Date
    July 28, 2011
    Manufacturer
    UNKNOWN
    Product Code
    FMW
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2011 - (B)(4) - A RETROSPECTIVE REVIEW OF THE ADVERSE EVENT FILE AN MDR WAS NEEDED. CONCULSION - THE CONSUMER WAS A SMOKER. IN ADDITION, A TOXICOLOGY REPORT INDICATED THAT THE CONSUMER HAD A BLOOD ALCOHOL OF .263 AT THE TIME OF DEATH.

    Additional Manufacturer Narrative · 1

    (B)(4) 2011 - (B)(4) - A RETROSPECTIVE REVIEW OF THE ADVERSE EVENT FILE AN MDR WAS NEEDED. CONCLUSION - THE CONSUMER WAS A SMOKER. IN ADDITION, A TOXICOLOGY REPORT INDICATED THAT THE CONSUMER HAD A BLOOD ALCOHOL OF .263 AT THE TIME OF DEATH. UPDATE: (B)(4) 2011 - (B)(4) - A RETROSPECTIVE REVIEW OF THE ADVERSE EVENT FILE WAS PERFORMED. CONCLUSION - THE CONSUMER WAS A SMOKER. IN ADDITION, A TOXICOLOGY REPORT INDICATED THAT THE CONSUMER HAD A BLOOD ALCOHOL LEVEL OF .263 AT THE TIME OF THE DEATH. THE COUNTY FIRE MARSHALL STATED THAT A LIT CIGARETTE WAS THE CAUSE OF THE FIRE. THE MATTRESS MANUFACTURER AND THE AGE OF THE MATTRESS ARE UNKNOWN. THE FIRE MARSHALL CONCLUDED TWO POSSIBLE SCENARIOS: A LIT CIGARETTE CAUSED THE BED LINENS TO IGNITE, AND A LIT CIGARETTE CAUSE THE TRASH CAN NEXT TO THE BED TO CATCH FIRE IGNITING THE COMBUSTIBLE MATERIALS NEXT TO THE BED. NEITHER OF THESE SCENARIOS ARE SUGGESTIVE THAT AN INVACARE PRODUCT MALFUNCTIONED.

    Description of Event or Problem · 1

    A CONSUMER DIED WHEN HE ALLEGEDLY FELL ASLEEP ON AN INVACARE BED WITH A LIT CIGARETTE.

    Description of Event or Problem · 1

    A CONSUMER DIED WHEN HE ALLEGEDLY FELL ASLEEP ON AN INVACARE BED WITH A LIT CIGARETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATTRESS COVER FOR MEDICAL PURPOSES 880.6190 FMW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death