BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROLLATOR,SUPER LIGHT,250LB CAP.

    MDR report key: 17683107 · Received September 5, 2023

    Report

    Report Number
    1417592-2023-00360
    Event Type
    Death
    Date Received
    September 5, 2023
    Date of Event
    July 8, 2023
    Report Date
    September 5, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    ITJ
    UDI-DI
    00311917124711
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER ON (B)(6) 2023 HER FATHER "WAS WALKING WITH THE ROLLATOR TO THE BATHROOM AND TURNED THE DEVICE AROUND TO SIT STATIONARY BY THE SINK". PER THE CUSTOMER HER FATHER "SAT DOWN" ON THE STATIONARY DEVICE, BUT WAS UNABLE TO CONFIRM IF THE BRAKES WERE APPLIED WHEN SITTING. PER THE CUSTOMER WHEN HER FATHER SAT DOWN "THE BACK LEFT LEG SNAPPED JUST BELOW THE WELD BY THE CROSS BAR, THROWING THEM BACK AND HITTING THEIR HEAD ON THE BATHROOM TUB". PER THE CUSTOMER HER FATHER WAS "ALERT" AND EMERGENCY SERVICES WERE CALLED. PER THE CUSTOMER HER FATHER WAS TAKEN TO THE EMERGENCY ROOM WHERE IMAGING WAS TAKEN WHICH CONFIRMED "NO HEAD INJURY, BUT REVEALED 2 SNAPPED VERTEBRAE". PER THE CUSTOMER HER FATHER WAS TRANSFERRED TO ANOTHER FACILITY FOR SURGERY, BUT WAS "UNABLE TO RECOVER FROM THE PROCEDURE AND PASSED ON (B)(6) 2023". PER THE CUSTOMER THE DEVICE WAS PURCHASED FROM WALGREENS APPROXIMATELY 4 YEARS AGO AND IS AVAILABLE FOR EVALUATION. THE SAMPLE WAS REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER ON (B)(6) 2023 HER FATHER "WAS WALKING WITH THE ROLLATOR TO THE BATHROOM AND TURNED THE DEVICE AROUND TO SIT STATIONARY BY THE SINK". PER THE CUSTOMER HER FATHER "SAT DOWN" ON THE STATIONARY DEVICE, BUT WAS UNABLE TO CONFIRM IF THE BRAKES WERE APPLIED WHEN SITTING. PER THE CUSTOMER WHEN HER FATHER SAT DOWN "THE BACK LEFT LEG SNAPPED JUST BELOW THE WELD BY THE CROSS BAR, THROWING THEM BACK AND HITTING THEIR HEAD ON THE BATHROOM TUB".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378705 ROLLATOR,SUPER LIGHT,250LB CAP. ITJ MEDLINE INDUSTRIES, LP 88515120056 00311917124711

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Death