According to the customer contact some time in november or december, the wheels came off the device while in use inside his home.It was reported that a fall occurred.After the fall, the customer went to the hospital where an xray was performed.The customer contact reports that the x-ray showed a "skull fracture".The device is used daily.The device was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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