BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROLLATOR,SUPER LIGHT,250LB CAP

    MDR report key: 8784780 · Received July 12, 2019

    Report

    Report Number
    1417592-2019-00114
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    April 1, 2019
    Report Date
    July 12, 2019
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    ITJ
    UDI-DI
    10311917124718
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE RIGHT FRONT WHEEL OF THE ROLLATOR BROKE OFF THE DEVICE AS THE END-USER WAS EATING AND TURNING AWAY FROM HER REFRIGERATOR. THE END-USER EXPERIENCED A FALL ONTO HER KITCHEN FLOOR. SHE WAS TAKEN TO A LOCAL HOSPITAL'S EMERGENCY DEPARTMENT (ED). NO ED DIAGNOSTIC EXAMS/RESULTS WERE REPORTED TO THE MANUFACTURER. THE END-USER STATED THAT SHE WAS DIAGNOSED WITH ASPIRATION PNEUMONIA AND WAS ADMITTED TO THE HOSPITAL FOR ONE WEEK AND WAS THEN ADMITTED TO A REHABILITATION FACILITY FOR TWENTY DAYS. NO ADMITTING DIAGNOSES FOR THE REHABILITATION FACILITY WAS REPORTED TO THE MANUFACTURER. WHEN THE END-USER WAS DISCHARGED FROM THE REHABILITATION FACILITY, SHE FOLLOWED UP WITH HER PHYSICIAN. REPORTEDLY, THE PHYSICIAN PERFORMED UNIDENTIFIED X-RAY EXAMS AND THE END-USER WAS DIAGNOSED WITH A RIGHT THUMB FRACTURE. NO MEDICAL TREATMENTS RELATED TO THE DIAGNOSED RIGHT THUMB FRACTURE WAS REPORTED TO THE MANUFACTURER. ACCORDING TO THE END-USER SHE IS CURRENTLY RECEIVING HOME HEALTH CARE FROM A NURSE, HOWEVER, THE DIAGNOSE WHICH LEAD TO THE NEED FOR HOME HEALTH CARE WAS NOT IDENTIFIED. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. DUE TO THE REPORTED ADMISSIONS AND THE RIGHT THUMB FRACTURE, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ROLLATOR WHEEL BROKE OFF THE DEVICE AND THE END-USER EXPERIENCED A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577304 ROLLATOR,SUPER LIGHT,250LB CAP ITJ MEDLINE INDUSTRIES INC. 88516120037 10311917124718

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| S