BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROLLATOR

    MDR report key: 3143177 · Received May 24, 2013

    Report

    Report Number
    1417592-2013-00047
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE REACHING FOR THE ROLLATOR, THE HAND GRIP APPARENTLY CAME OFF AND THE END USER FELL, FRACTURING HIS HIP. HE WAS SUBSEQUENTLY HOSPITALIZED AND SURGERY WAS PERFORMED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE SENT. IT IS NOT KNOWN IF MAINTENANCE HAD BEEN PERFORMED ON THE DEVICE DURING THE TIME IT WAS OWNED BY THE END USER. WE HAVE HAD NO OTHER SIMILAR INCIDENTS REPORTED TO US FOR THIS DEVICE. THE OVERALL CONDITION OF THE DEVICE IS NOT KNOWN. WE HAVE NOT CONFIRMED THE ISSUE OR IDENTIFIED A ROOT CAUSE. HOWEVER, DUE TO THE REPORTED INJURY AND SUBSEQUENT HOSPITALIZATION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE HAND GRIP CAME OFF THE ROLLATOR AND THE END USER FELL, FRACTURING HIS HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232734 ROLLATOR ITJ MEDLINE INDUSTRIES, INC. H100113302

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R