BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAZZ STANDARD ROLLATOR 9153653681

    MDR report key: 9588326 · Received January 14, 2020

    Report

    Report Number
    9615290-2020-00001
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    May 29, 2018
    Report Date
    May 29, 2018
    Manufacturer
    INVACARE SWEDEN, REA (DOLOMITE)
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    END USER'S NURSE (RN) STATED THAT HER PATIENT WAS WALKING TOWARDS A RESTAURANT WITH HIS JAZZ STANDARD ROLLATOR WHEN THE UNIT WOBBLED CAUSING HIM TO ALLEGEDLY LOSE HIS BALANCE AND FALL, SUSTAINING ABRASIONS TO HIS LEFT KNEE AND BACK (LEFT OF THE SPINE). THE USER WAS TAKEN TO THE HOSPITAL BY AMBULANCE FOR ASSESSMENT AND X-RAYS CONFIRMED A FRACTURED LEFT POSTERIOR RIB. THE USER WAS NOT ADMITTED TO THE HOSPITAL NOR THE ER. HE WAS TREATED AND RELEASED BEING PRESCRIBED PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50346 JAZZ STANDARD ROLLATOR 9153653681 WALKER/ROLLATOR ITJ INVACARE SWEDEN, REA (DOLOMITE) NA:JAZZSTD

    Patients

    Seq Age Sex Outcome Treatment
    1