BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 2603276 · Received May 18, 2012

    Report

    Report Number
    2438477-2012-00009
    Event Type
    Injury
    Date Received
    May 18, 2012
    Date of Event
    December 3, 2011
    Report Date
    April 19, 2012
    Manufacturer
    MAXHEALTH CORP
    Product Code
    NXE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL HAS RECEIVED A COMPLAINT FROM AN PHARMACY¿S INSURANCE COMPANY ABOUT AN INCIDENT INVOLVING A CRUTCH ORIGINALLY DISTRIBUTED BY DRIVE MEDICAL. IT IS ALLEGED THAT THE END USER WAS USING THE CRUTCH WHEN IT TWISTED CAUSING THE END USER TO FALL. THE CLAIMANT ALLEGEDLY SUSTAINED A FRACTURE AT THE BASE OF THE LEFT METATARSAL, BRUISING AND CONTUSION. THE CLAIMANT¿S ATTORNEY REFUSED TO RELEASE ADD¿L INFO PERTAINING TO THE INJURIES. THIS MDR REPORT IS BASED ON THE INSURANCE COMPANY COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL EZ ADJUST ALUMINUM CRUTCHES NXE MAXHEALTH CORP 10430-8 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention