FDA.reportPublic FDA data

MAUDE MDR 7075776

MDR report key
7075776
Report number
3007966929-2017-00073
Event key
0
Event type
3
Date of event
2017-11-09
Date received
2017-12-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1URINE METERDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLEFFG158101310190307503N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-010

Event Narratives#

N

Patient 1

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED BUT NONE HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

D

Patient 1

A NURSE REPORTED THAT ?THE TUBE OF THE UNOMETER IS NOT ALLOWING SMALL AMOUNT OF URINE TO GO WITH GRAVITY.? IT WAS REPORTED THAT APPROXIMATELY 1 HOUR AFTER CONNECTING THE UNOMETER TO THE CATHETER, THE CARE PROVIDER NOTED URINE WAS BACKING UP IN THE INLET TUBING. IT WAS FURTHER REPORTED THAT THE TUBE OF THE UNOMETER HAD TO BE LIFTED EVERY HOUR IN ORDER FOR THE URINE TO FLOW. THERE WAS NO FLOW OF URINE INTO THE MEASURING CHAMBER WITHOUT MANIPULATION OF THE TUBE. AFTER MANIPULATION OF THE TUBE, APPROXIMATELY 20-30ML OF URINE ENTERED THE MEASURING CHAMBER. THERE WAS NO HARM TO THE PATIENT. THIS IS REPORT IS FOR THE SECOND DEVICE USED ON THE PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED, INCLUDING IF A REPLACEMENT DEVICE WAS USED.