FDA.reportPublic FDA data

MAUDE MDR 8782263

MDR report key
8782263
Report number
2951238-2019-01002
Event key
0
Event type
3
Date of event
2019-06-14
Date received
2019-07-11
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. CONNIE TUBERA
Address
2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VIZISHOT 2 FLEXSINGLE USE ASPIRATION NEEDLEGYRUS ACMI, INC.KTINA-U403SX-4019FR855136N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-07-110

Event Narratives#

No narrative records found.