(b)(4) is the initial importer of the device which is a wheelchair.The unit is being returned for evaluation which is delayed due to covid-19 related issues.End-user was given the chair after knee surgery.She used the unit for approximately 2 months.The wheel lock on the left side was loose.The unit to slide from under her and she fell.The service provider sent reps to tightened the wheel lock/brake and replaced the foot pedal because it broke.It became loose again.She reportedly fell three to four times while using the unit once landing on her backside, once on her face.She bruised her forehead and busted her lip.The first time she landed on her butt.The second time she fell she hit her head and bruised her forehead.Busted her lip.She found little black washers on the floor and a thin wire.She did not seek medical attention.
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