FDA.reportPublic FDA data

MAUDE MDR 8506100

MDR report key
8506100
Report number
2517506-2019-00152
Event key
0
Event type
3
Date of event
2019-03-14
Date received
2019-04-11
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
JAMES MORGERA
Address
500 GBC DRIVE PO BOX 6101 NEWARK DE 19714 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DIMENSION VISTA?DIMENSION VISTA? ALPHA-FETOPROTEIN FLEX? REAGENT CARTRIDGESIEMENS HEALTHCARE DIAGNOSTICS INCLOJK6454 SMN 1046337818309BEN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-110

Event Narratives#

No narrative records found.