FDA.reportPublic FDA data

MAUDE MDR 9245057

MDR report key
9245057
Report number
3002637618-2019-00116
Event key
0
Event type
3
Date of event
2019-07-01
Date received
2019-10-28
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
FELIX AKINRINOLA
Address
2 EDGEWATER DRIVE NORWOOD MA 02062 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CLINITEK STATUS+CLINITEK STATUS+SIEMENS HEALTHCARE DIAGNOSTICSJIL10379675N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-280

Event Narratives#

No narrative records found.