MAUDE MDR 8735347

MDR report key
8735347
Report number
2951238-2019-00974
Event key
0
Event type
3
Date received
2019-06-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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.KTIFR825276UNKNOWNN R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-06-260

Event Narratives#

No narrative records found.