BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 2603258 · Received May 31, 2012

    Report

    Report Number
    2438477-2012-00010
    Event Type
    Injury
    Date Received
    May 31, 2012
    Date of Event
    April 21, 2012
    Report Date
    May 1, 2012
    Manufacturer
    SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.
    Product Code
    NXE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL HAS RECEIVED A COMPLAINT FROM CLAIMANT¿S DAUGHTER ABOUT AN INCIDENT INVOLVING A ROLLATOR, ALLEGEDLY DISTRIBUTED BY DRIVE MEDICAL. IT IS REPORTED THAT THE END USER HAD BEEN USING THE ROLLATOR FOR ONE YEAR. ON THE DAY OF INCIDENT, THE CLAIMANT WAS IN THE LOBBY OF HIS BUILDING WHEN HE LOCKED THE BRAKES AND WENT TO SIT DOWN. THE BRAKES ALLEGEDLY DISTRIBUTED BY DRIVE MEDICAL. IT IS REPORTED THAT THE END USER HAD BEEN USING THE ROLLATOR FOR ONE YEAR. ON THE DAY OF INCIDENT, THE CLAIMANT WAS IN THE LOBBY OF HIS BUILDING WHEN HE LOCKED THE BRAKES AND WENT TO SIT DOWN. THE BRAKES ALLEGEDLY DID NOT LOCK CORRECTLY AND THE ROLLATOR SLIPPED AWAY CAUSING HIM TO FALL AND ALLEGEDLY SUSTAINED HEAD INJURY RESULTING IN RECEIVING SIX (6) STITCHES. DRIVE HAS BEEN REACHING OUT TO THE CLAIMANT¿S DAUGHTER AND TRIED TO HAVE THE ALLEGED PRODUCT RETURNED FOR FURTHER INSPECTION. AS OF THIS DATE, THEY HAVE REFUSED TO DO SO. THIS MDR IS BASED ON THE CLAIMANT¿S DAUGHTER COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL ROLLATOR NXE SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO. RTL728RD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention