BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE QRI

    MDR report key: 16196480 · Received January 18, 2023

    Report

    Report Number
    9616084-2023-00001
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 5, 2022
    Report Date
    January 18, 2023
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BACKGROUND INFORMATION: QUICKIE QRI WHEELCHAIR OWNER'S MANUAL, REV. D, PAGE 6 STATES: "2. YOUR CHAIR IS DESIGNED FOR USE ON FIRM, EVEN SURFACES SUCH AS CONCRETE, ASPHALT, INDOOR FLOORING, AND CARPETS." DISCUSSION: IN REVIEWING THE COMPLAINT, THE TECHNICIAN REPORTS THAT THE USER CLAIMED THAT WHILE SITTING IN A STATIONARY POSITION ON AN UNEVEN SURFACE, THE RIGHT ANTI-TIP BROKE OFF, ALLEGEDLY LEADING TO THE END USER FALLING OUT OF THE CHAIR. THERE ARE NO DETAILS ON WHAT TYPE OF SURFACE THE REPORTED INCIDENT OCCURRED ON OR WHAT LED TO THE ANTI-TIP BREAKING OFF. THE TECHNICIAN WAS UNSURE IF THERE WERE ANY INFLUENTIAL ENVIRONMENTAL ELEMENTS WHEN THE INCIDENT OCCURRED. THE MOST LIKELY ROOT CAUSE COULD BE THE END USER USING THE WHEELCHAIR ON AN UNEVEN SURFACE, DISRUPTING THE CENTER OF BALANCE, AND POTENTIALLY CAUSING A SHIFT IN THE LOAD PATH, LEADING TO MATERIAL BREAKAGE AND THE ANTI-TIP TO FAIL. THE END USER ALLEGEDLY BROKE HIS FEMUR WHILE ATTEMPTING TO GET BACK INTO HIS WHEELCHAIR AFTER THE FALL. THE USER REPORTED TO THE TECHNICIAN THAT THEY HAD A FOLLOW UP APPOINTMENT FOR THE ALLEGED BROKEN FEMUR. THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED ON THE END USER'S CURRENT CONDITION OR TREATMENT. CONCLUSION: DUE TO THE ALLEGATION OF A SERIOUS INJURY (BROKEN FEMUR) THAT REQUIRED MEDICAL INTERVENTION, THIS MDR IS BEING FILED.

    Description of Event or Problem · 0

    TECHNICIAN REPORTS THAT WHILE THE USER WAS SITTING ON AN UNEVEN SURFACE, THE RIGHT ANTI TIP BROKE OFF, CAUSING THE USER TO FALL FROM THE CHAIR. THE END USER REPORTEDLY BROKE HIS FEMUR WHILE ATTEMPTING TO GET BACK INTO HIS WHEELCHAIR. THERE IS LIMITED INFORMATION ON THE INCIDENT AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15673 QUICKIE QRI WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC QUICKIE QRI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| R