FDA.reportPublic FDA data

MAUDE MDR 9849886

MDR report key
9849886
Report number
1220948-2020-00035
Event key
0
Event type
3
Date of event
2020-02-19
Date received
2020-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. PRAGYA THIKEY
Address
63 SECOND AVE BURLINGTON, MA US
Phone
221-221-2212
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PRUITT F3 CAROTID SHUNTCAROTID SHUNTLEMAITRE VASCULAR, INC.MJNe2012-10E2012-10PFT3595Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-180

Event Narratives#

No narrative records found.