FDA.reportPublic FDA data

MAUDE MDR 6761821

MDR report key
6761821
Report number
3007966929-2017-00039
Event key
0
Event type
3
Date received
2017-08-02
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, DISPOSABLEFFG25001183N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-020

Event Narratives#

N

Patient 1

(B)(4). (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A PRODUCT MALFUNCTION. THIS REPORT IS ABOUT AN UNKNOWN NUMBER OF PATIENTS AND DEFECTIVE UNITS. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

D

Patient 1

THIS REPORT IS ABOUT AN UNKNOWN NUMBER OF PATIENTS AND DEFECTIVE UNITS. COMPLAINT RECEIVED FROM A HOSPITAL IN (B)(6) REPORTING THAT "THE PROBLEM IS THAT WHEN THEY CONNECTED THE CATHETER TO THE UNOMETER, THE URINE DOES NOT FLOW. EVEN IN THE OPERATING ROOM THEY HAD ALREADY OBSERVED THE SAME PROBLEM." CLARIFICATION WAS OBTAINED: REPORTER STATED THAT BEFORE THE DEVICE WAS ATTACHED TO THE INDWELLING CATHETER, "THE URINE FLOWED WITHOUT ANY PROBLEM. HOWEVER, AT THE TIME OF THE PLACEMENT OF THE DEVICE, THE PROFESSIONALS OBSERVED A SIGNIFICANT DECREASE IN THE URINE DESCENT." NO FURTHER INFORMATION WAS PROVIDED INCLUDING PATIENT INFORMATION OR OUTCOMES.