BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 2556015 · Received April 27, 2012

    Report

    Report Number
    2438477-2012-00007
    Event Type
    Injury
    Date Received
    April 27, 2012
    Report Date
    March 29, 2012
    Manufacturer
    UNKNOWN
    Product Code
    NXE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL HAS RECEIVED A COMPLAINT FROM AN ATTORNEY ABOUT AN INCIDENT INVOLVING A ROLLATOR, ALLEGEDLY DISTRIBUTED BY (B)(4). IT IS REPORTED THAT THE ROLLATOR BUCKLED AND BENT CAUSING THE CLAIMANT TO FALL AND SUSTAIN SERIOUS INJURIES REQUIRING HOSPITALIZATION AND OTHER CARE. THIS MDR REPORT IS BASED ON THE CUSTOMER COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL ROLLATOR NXE UNKNOWN 750NB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R