(b)(4) is the initial importer of the device which is a hospital bed.The device has not been returned for evaluation.We will be filing a follow-up when additional information is available.We are submitting this report in an overabundance of caution and to be timely.The end-user is nonverbal.While under caregiver supervision the occupant fell out of the device.She landed face down and hit her eye.She sustained a bump on her eye.They were waiting for the doctor to do an x ray and make sure everything was ok.A follow-up visit is expected from the doctor.The caregiver believes that a piece, a screw, is missing off the rail on one side of the device.She is unaware of when this piece became missing.She is seeking reimbursement for the repairs of the unit and a technician coming.
|