The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
A peritoneal dialysis (pd) patient experienced relapsed peritonitis which was manifested by cloudy fluid. The cause of the event was not reported. It was not reported if the patient was hospitalized for the event. The patient was treated with gentamycin (dose, route, frequency and duration not reported) for peritonitis. At the time of this report, treatment was completed and the patient has now fully recovered from the event. Action taken with pd therapy was not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5