BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPORTEDLY MAY HAVE HAD A ROHO CUSHION

    MDR report key: 2817460 · Received October 24, 2012

    Report

    Report Number
    1419507-2012-00001
    Event Type
    Death
    Date Received
    October 24, 2012
    Date of Event
    June 20, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROHO HAS BEEN UNABLE TO ASCERTAIN MUCH INFO. WE DO KNOW THAT THE CORONER RULED THE DEATH ACCIDENTAL AND THAT NO SPECIFIC ATTENTION WAS PAID TO THE CUSHION DURING THE INQUEST. WE DO NOT KNOW IF THE CUSHION IN QUESTION WAS IN FACT A ROHO DEVICE. MOST OF THE INFO CAME FROM A NEWSPAPER ARTICLE IN (B)(6) IN (B)(6). ROHO REQUESTED ADDITIONAL INFO FROM OUR DISTRIBUTOR, (B)(4). (B)(4) SPOKE WITH THE CORONER WHO CONFIRMED WHAT WAS STATED ABOVE THAT HE DIDN'T KNOW WHERE THE CUSHION ENDED UP, AND THAT THE PT WAS ON THE SOFA WHICH CAUGHT FIRE. FURTHER, ROHO COVERS PASS CAL 117 AND (B)(4) PLUS NEOPRENE CUSHIONS PASS CRIB 5 TESTS, THEREFORE IT IS UNLIKELY THAT THEY WOULD HAVE CAUGHT ON FIRE FROM A SMOLDERING CIGARETTE. (B)(4) ALSO SPOKE WITH (B)(6) WHO CONFIRMED THAT SHE DID NOT KNOW WHAT CUSHION THE PT HAD, BUT PRESUMED IT WAS A ROHO, BUT IF SO, HAD NO IDEA AS TO MAKE, MODEL, OR DATE. (B)(6) LOANS EQUIPMENT TO PTS. SOME EQUIPMENT IS PURCHASED BY THE TRUST AND OTHERS DONATED BY PTS UPON THEIR DEATH. SHE DOES NOT HAVE THE CUSHION IN QUESTION, ALTHOUGH PRESUMABLY THEY OWNED THE PRODUCT. SHE FURTHER CONFIRMED THAT THE PT WAS A SMOKER BASED UPON CIGARETTE BUTTS FOUND ALL OVER HIS HOUSE. (B)(4).

    Description of Event or Problem · 1

    PT REPORTEDLY WAS SMOKING WHILE SITTING ON A THERAPEUTIC CUSHION WHILE SITTING ON A SOFA. PRESUMABLY, THE SOFA CAUGHT FIRE. THE PT'S NEXT DOOR NEIGHBOR AND CAREGIVER, TO WHOM HE WAS CONNECTED VIA INTERCOM, CAME TO HIS HOUSE WHEN SHE HEARD HIM SAY "I'M ON FIRE". SHE WET A TOWEL AND ROLLED HIM ON THE FLOOR. HE WAS TRANSFERRED VIA AIRLIFT TO (B)(6) HOSPITAL WITH REPORTEDLY HAVING 30% OF HIS BODY BURNED. HE DIED THERE 9 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPORTEDLY MAY HAVE HAD A ROHO CUSHION FLOTATION CUSHION KIC ROHO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death DO NOT KNOW. (B)(6) LOANED| CUSHION TO PATIENT. PATIENT WAS SITTING ON CUSHION| ON A SOFA AND SMOKING.