BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 2033333 · Received March 24, 2011

    Report

    Report Number
    3004822415-2011-00005
    Event Type
    Death
    Date Received
    March 24, 2011
    Date of Event
    April 24, 2010
    Report Date
    February 17, 2011
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION OF THE EVENT OR PROBLEM UNK. CAIRE WAS NOTIFIED OF THE ALLEGED DEATH OF A PT ON (B)(6) 2011, BY A LEGAL COUNSELOR. THE ORIGINAL LETTER WAS SENT TO COVIDIEN AND DATED (B)(6) 2011. THE LETTER DID NOT PROVIDE ANY INFO REGARDING THE DESCRIPTION OF THE INCIDENT OR ANY PRODUCT INFO. THE LETTER ALSO DID NOT STATE HOW/OR IF A CAIRE OXYGEN TANK WAS INVOLVED WITH THE DEATH. CAIRE HAS MADE SEVERAL ATTEMPTS TO CONTACT THE LEGAL COUNSELOR GROUP THAT SENT THE ORIGINAL LETTER, PER THE FOLLOWING: CALLED AND LEFT VOICEMAIL ON (B)(6) 2011, SENT MAIL ON (B)(6) 2011, MAILED FORMAL RESPONSE LETTER ON (B)(6) 2011. CAIRE HAS RECEIVED NO FURTHER INFO OR CONTACT REGARDING THE ALLEGED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN BYJ CAIRE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death