(b)(4) is the initial importer of the device which is a walker.(b)(4) has not received the unit back for evaluation.Weight cap on the device is 300 pounds.End-user's reported weight is (b)(6).End user was sitting in the device while being pushed out of doors.The device hit a bump in the pavement and the user fell out of the unit.She was taken by ambulance to the medical center where x-rays were performed.She was informed that she had trauma in her leg.She stayed overnight.The next day she had trouble walking and went to another hospital where she was admitted by 4 day with a diagnosis of hematoma on her leg muscles.Treatment was to allow the trauma to dissipate on its own.After hospital release, end-user fell again without the use of the device.
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