FDA.reportPublic FDA data

MAUDE MDR 9377603

MDR report key
9377603
Report number
3005168196-2019-02208
Event key
0
Event type
3
Date of event
2019-10-31
Date received
2019-11-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. VERONICA FARRIS
Address
ONE PENUMBRA PLACE ALAMEDA CA 94502 US
Phone
510-510-5107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INDIGO SYSTEM ASPIRATION CATHETER 6QEWPENUMBRA, INC.QEWCAT6KITF90045 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-260

Event Narratives#

No narrative records found.