FDA.reportPublic FDA data

MAUDE MDR 8964181

MDR report key
8964181
Report number
3005099803-2019-04409
Event key
0
Event type
3
Date of event
2019-06-01
Date received
2019-09-05
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CAROLE MORLEY
Address
300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SENSORSTYLET FOR CATHETER, GASTRO-UROLOGYBOSTON SCIENTIFIC CORPORATIONEZBM0066703051670-305Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-050

Event Narratives#

No narrative records found.