(b)(4) is the initial importer of the device which is a rollator.We were notified of the incident by a letter written by the end-user's spouse.We do not expect return of the device for evaluation.A follow-up report will be filed if new information is received.The user was ona cement path in the park when they transitioned the rollator into a transport chair by turning the backrest around, and pulling out the foot rest.He sat down and the caregiver started to push him.At a crack in the sidewalk the wheels locked.The user was thrown off the seat and onto the cement, face first.He suffered a broken nose, 2 black eyes, cuts under his eyes, many bruises and lacerations, and a hit on the head.He was taken by the ems to the hospital where he was treated for lacerations and a broken nose.He remained overnight.Instructions clearly state to "do not use seat when unit is on incline or uneven ground.".
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