BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRGO

    MDR report key: 4841502 · Received June 8, 2015

    Report

    Report Number
    8022077-2015-00002
    Event Type
    Death
    Date Received
    June 8, 2015
    Date of Event
    March 3, 2015
    Report Date
    June 8, 2015
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR TENDING TO THE PT WAS THE ONE THAT (B)(6) OF THE INCIDENT AND SUBSEQUENT DEATH. THE INCIDENT OCCURRED ON (B)(6) 2015 AND THE PT DIES ON (B)(6) 2015. A HEALTH (B)(6) SPECIALIST INFORMED AMG MEDICAL INC., OF THE INCIDENT/EVENT ON (B)(6) 2015. AMG CONTACTED THE DOCTOR LINKED TO THIS CASE ON (B)(6) 2015 AND REQUESTED THE ROLLATOR BE RETURNED TO AMG FOR FURTHER TESTING AND INVESTIGATION. NO ANSWER WAS RECEIVED FROM THE DOCTOR; THEREFORE, A F/U WAS SENT TO HER ON (B)(6) 2015. ON (B)(6) /2015, THE DOCTOR INFORMED AMG THAT THE UNIT IN QUESTION IS CURRENTLY UNDERGOING INDEPENDENT EXAMINATION. WHEN THEY RECEIVED THE UNIT BACK IN THEIR POSSESSION, THEY WILL SEND IT TO US. AS OF TODAY, WE HAVE NOT RECEIVED THE ROLLATOR BACK.

    Description of Event or Problem · 1

    PT WAS SITTING ON HER WHEELED WALKER, POSSIBLY PROPELLING WITH HER FEET. FRONT WHEEL BOLT SHEARED SUDDENLY. WALKER FELL OVER AND PT LANDED ON THE GROUND, STRIKING HER HEAD ON KITCHEN CABINETRY. SHE DIED OF A SUBDURAL HEMATOMA RELATED TO THIS FALL, 48 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368038 AIRGO AIRGO EXCURSION ROLLATOR ITJ AMG MEDICAL INC. 700-921

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| H