BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 1200543 · Received October 15, 2008

    Report

    Report Number
    2438477-2008-00009
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 3, 2008
    Report Date
    October 14, 2008
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CLAIMANT WAS USING THE ROLLATOR ON SIDEWALK AND ROLLATOR ALLEGEDLY STOPPED AND FOLDED UP ON ITSELF, CAUSING CLAIMANT TO FALL ON TOP OF THE ROLLATOR. SEAT AND GONE UP LEAVING THE SEAT PINS EXPOSED AND ALLEGEDLY CAUSING CLAIMANT TO SUSTAIN INJURY ON BOTH SHINS. THE CLAIMANT DID NOT RECEIVE MEDICAL ATTENTION THE DAY OF INJURY; HOWEVER, THE FOLLOWING DAY, HAD A DERMATOLOGY APPOINTMENT AND WHILE THERE, SHE SHOWED THE DERMATOLOGIST THE INJURY, WHO SUTURED HER SHINS. IT IS ALLEGED THAT THE RIGHT SHIN REQUIRED NINE (9) STITCHES AND LEFT SHIN REQUIRED TWENTY-TWO (22) STITCHES. THE ALLEGED ROLLATOR HAS NOT BEEN RETURNED TO DRIVE FOR IDENTIFICATION AND EVALUATION. NO INFORMATION ON THE MAINTENANCE HISTORY OF THE DEVICE IS CURRENTLY AVAILABLE. IT'S UNCLEAR OF THE NATURE OF THE AREA WHERE THE ALLEGED EVENT OCCURRED, AND THAT WHETHER ANY IMPACT HAS CONTRIBUTED TO THE ALLEGED EVENT. THIS MDR REPORT IS BASED ON THE INJURY CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL ROLLATOR JR. ITJ NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention