FDA.reportPublic FDA data

MAUDE MDR 1645772

MDR report key
1645772
Report number
1645772
Event key
0
Event type
3
Date of event
2010-01-12
Date received
2010-03-11
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
1BVI9400BLADDER SCANNERVERATHONEXQBVI9400NANA R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-03-110

Event Narratives#

D

Patient 1

THE READINGS ON THE BLADDER SCANNER THE NURSE WAS USING WERE NOT CONSISTENT WITH THE READINGS FROM ANOTHER ONE.