FDA.reportPublic FDA data

MAUDE MDR 6807554

MDR report key
6807554
Report number
6807554
Event key
0
Event type
3
Date of event
2013-09-13
Date received
2017-08-21
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
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1N/ADEVICE, CYSTOMETRIC, HYDRAULICMFR UNKNOWNFEN* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-210

Event Narratives#

N

Patient 1

D

Patient 1

BLADDER PRESSURE MONITORING DEVICE MALFUNCTION. DISCOVERED THAT PREDETERMINED AMOUNT OF NS INSTILLED INTO BLADDER DID NOT RETURN/DRAIN. REMOVED DEVICE FROM FOLEY CATHETER AND >300 ML DRAINED FROM BLADDER.