This report or other information submitted by joerns healthcare under 21 cfr part 803, and release by the fda of that report information, does not reflect a conclusion or admission by joerns healthcare , its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.
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It was reported to the manufacturer, by the end user, per the end user, that the air mattress would start to deflate and the patient would fall off the side of the bed, he fell out the mattress twice.Rn did not know very many details about the incident.I asked if the patient had to go to the hospital or if there were injuries.Complaint (b)(4) and (b)(4) were entered into our system to have the products returned.As of this writing, the products have not been returned.
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