BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DS Z-SERIES FOLDING ROLLATOR

    MDR report key: 5957105 · Received September 16, 2016

    Report

    Report Number
    3005182235-2016-00030
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    August 26, 2016
    Report Date
    September 16, 2016
    Manufacturer
    MAXHEALTH CORP.
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING EVENT HAD OCCURRED AT 2:22 PM ON (B)(6) 2016: A RESIDENT (END-USER) WAS IN THE COMMON AREA, GOING TO A PLANNED ACTIVITY. SHE ARRIVED AT THE ACTIVITY, AND TRIED TO SIT ON THE ROLLATOR'S SEAT. THE WHEEL FELL OFF THE UNIT, CAUSING THE RESIDENT TO MISS THE SEAT AND FALL ON HER SHOULDER ON THE TILE FLOOR. THE FOLLOWING INJURIES ALLEGEDLY OCCURRED: THE RESIDENT (END-USER) FRACTURED HER HUMERUS. THE INJURED PARTY WAS TREATED AT A HOSPITAL/CLINIC, AND RELEASED. THE FACILITY SAID THAT THERE WAS ONE OTHER PERSON PRESENT AT THE TIME THE INCIDENT HAD OCCURRED - THE ACTIVITY DIRECTOR. THE PRODUCT HAS SINCE BEEN TAKEN OUT OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607912 DS Z-SERIES FOLDING ROLLATOR ROLLATOR ITJ MAXHEALTH CORP. DS8DRL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R