BEUDAMED
    FDA Adverse Event Death Summary report: N

    NON IVC PRODUCT

    MDR report key: 1012525 · Received March 12, 2008

    Report

    Report Number
    1525712-2008-00021
    Event Type
    Death
    Date Received
    March 12, 2008
    Date of Event
    June 4, 2007
    Report Date
    March 10, 2008
    Manufacturer
    PROBASICS BY PMI
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSURANCE COMPANY'S INVESTIGATOR ALLEGES MANUFACTURER'S DEVICE CAUSED FIRE. NO FIRE REPORT HAS BEEN OBTAINED FROM LOCAL FIRE DEPARTMENT. HOWEVER, THE INSURANCE ELECTRICAL ENGINEER WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE FAILURE WITHIN THE ALLEGED DEVICE. AS A CONSERVATIVE MEASURE MDR FILED BASED ON ALLEGED DEATH.

    Description of Event or Problem · 1

    THE LETTER FROM THE ATTORNEY, SENT TO PMI, ALLEGES A PROBASICS NEBULIZER WAS THE CAUSE OF A FATAL FIRE IN AN APARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON IVC PRODUCT NONE CAF PROBASICS BY PMI UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death