FDA.reportPublic FDA data

MAUDE MDR 9147037

MDR report key
9147037
Report number
9680353-2019-00032
Event key
0
Event type
3
Date of event
2019-09-03
Date received
2019-10-02
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
MR. DANIEL DAVY
Address
5960 HEISLEY ROAD MENTOR OH 44060 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYSTEM 1E PROCESSORSYSTEM 1E PROCESSORSTERIS CANADA CORPORATIONMEDY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-020

Event Narratives#

No narrative records found.