It was reported the patient was admitted to the intensive care unit with 'severe burns' and, on an unknown date, was catheterized.An urinometer was connected to the patient's catheter.Post-connection, the nurse noted the urinometer was not draining at the connection between the foley catheter and the measuring chamber and the patient 'showed [signs of] urinary retention'.After manipulating the device, 'five hundred milliliters of urine exit [ed] the body'.No further patient complications were reported.
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Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Additional patient/event details have been requested.Should additional information become available, a follow-up report will be submitted.This complaint involves one known device and an unknown number of devices with the same complaint; therefore, one fda 3500a will be submitted for the known device and one fda 3500a for the unknown number of devices.
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