FDA.reportPublic FDA data

MAUDE MDR 9193094

MDR report key
9193094
Report number
1319809-2019-00101
Event key
0
Event type
3
Date of event
2019-09-12
Date received
2019-10-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JAMES A STEVENS
Address
100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US
Phone
585-585-5854
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VITROS CHEMISTRY PRODUCTS CREA SLIDESIN VITRO DIAGNOSTICSORTHO-CLINICAL DIAGNOSTICSJFY68025841519-3487-5358Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-150

Event Narratives#

No narrative records found.