BEUDAMED
    FDA Adverse Event Death Summary report: N

    SALTER LABS OXYGEN TUBING

    MDR report key: 6182966 · Received December 16, 2016

    Report

    Report Number
    3000219639-2016-00012
    Event Type
    Death
    Date Received
    December 16, 2016
    Date of Event
    November 9, 2016
    Report Date
    December 1, 2016
    Manufacturer
    SALTER LABS
    Product Code
    BYX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL AND FINAL REPORT. THIS IS A COMPANION REPORT TO USER REPORT 361562-2016-0004. PATIENT HAS MULTIPLE CONCURRENT MEDICAL CONDITIONS. EVENT INCLUDES FRACTURE AND HEMATOMA, ALTHOUGH THE PATIENT'S MEDICAL CONDITION INCLUDES DEGENERATIVE BONE DISEASE. BECAUSE OF THE DEGENERATIVE BONE DISEASE, IT CANNOT BE DEFINITIVELY STATED THAT THE PATIENTS FALL LED TO THE FRACTURES. PATIENT WAS ADMITTED TO THE HOSPITAL. DURING THE HOSPITAL STAY, THE PLEURAL EFFUSION INCREASED. PATIENT SUBSEQUENTLY EXPIRED ON (B)(6)2016. CAUSE OF DEATH NOT PROVIDED.

    Description of Event or Problem · 1

    THIS IS THE INITIAL AND FINAL REPORT. THIS IS A COMPANION REPORT TO USER REPORT 361562-2016-0004. DISTRIBUTOR REPORTS THAT THE PATIENT STATED SHE HAD TRIPPED OVER OXYGEN TUBING AND FELL, SUSTAINING INJURIES INCLUDING FRACTURED VERTEBRA AND HEMATOMA. PATIENT REPORTED MULTIPEL CONCURRENT PREEXISTING MEDICAL CONDITIONS INCLUDING HEART FAILURE, HYPERTENSION, ATRIAL FIBRILLATION, DRESSLERS SYNDROME, OSTEOPROSIS, CORONARY ARTERY DISEASE, PLEURAL EFFUSION, RHEUMATOID ARTHRITIS AND ISCHEMIC CARDIOMYOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832527 SALTER LABS OXYGEN TUBING OXYGEN TUBING BYX SALTER LABS 2025G NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death