BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_MEDICAL_PRODUCT

    MDR report key: 15771276 · Received November 10, 2022

    Report

    Report Number
    0001831750-2022-01216
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    October 9, 2022
    Report Date
    April 14, 2023
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED CONCLUDED THE SIDERAIL ALLEGEDLY LOWERING UNEXPECTEDLY WAS NOT DUE TO ANY COMPONENT LEVEL MALFUNCTION, AS THE HOSPITAL BIOENGINEERING DEPARTMENT VERIFIED FUNCTIONALITY OF ALL STRETCHERS IN THE EMERGENCY DEPARTMENT. THE USER FACILITY WAS UNABLE TO IDENTIFY THE MODEL OR SERIAL NUMBER OF THE STRETCHER INVOLVED IN THE EVENT. THE NURSE INVOLVED RECEIVED UNDISCLOSED MEDICAL TREATMENT FROM A PHYSICIAN, MISSED TIME FROM WORK, AND HAS SINCE RETURNED TO WORK. THE PATIENT WAS UNHARMED DURING THIS ALLEGED EVENT.

    Additional Manufacturer Narrative · 0

    THIS RECORD WAS ORIGINALLY CLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM. UPON COMPLETION OF THE INVESTIGATION, IT WAS DETERMINED THAT THERE WAS NO DEFECT WITH THE DEVICE AND FULL FUNCTIONALITY OF THE DEVICE WAS CONFIRMED. THE RECORD HAS BEEN ADJUSTED TO REFLECT ONLY AN ADVERSE EVENT, AND NOT A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE'S SIDERAIL WAS PUSHED DOWN BY THE PATIENT. CONSEQUENTLY, THE PATIENT FELL, AND THE NURSE SUSTAINED INJURIES, WHILE TRYING TO PREVENT THE PATIENT FALL. THE NURSE SUSTAINED A BACK INJURY, WHICH REQUIRED PROFESSIONAL MEDICAL TREATMENT, AND MISSED TIME FROM WORK. THE PATIENT WAS UNHARMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE'S SIDERAIL WAS PUSHED DOWN BY THE PATIENT. CONSEQUENTLY, THE PATIENT FELL, AND THE NURSE SUSTAINED INJURIES, WHILE TRYING TO PREVENT THE PATIENT FALL. THE NURSE SUSTAINED A BACK INJURY, WHICH REQUIRED PROFESSIONAL MEDICAL TREATMENT, AND MISSED TIME FROM WORK. THE PATIENT WAS UNHARMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE'S SIDERAIL WAS PUSHED DOWN BY THE PATIENT. CONSEQUENTLY, THE PATIENT FELL, AND THE NURSE SUSTAINED INJURIES, WHILE TRYING TO PREVENT THE PATIENT FALL. THE NURSE SUSTAINED A BACK INJURY, WHICH REQUIRED PROFESSIONAL MEDICAL TREATMENT, AND MISSED TIME FROM WORK. THE PATIENT WAS UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437721 UNKNOWN_MEDICAL_PRODUCT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other