FDA.reportPublic FDA data

MAUDE MDR 9903569

MDR report key
9903569
Report number
9612164-2020-01427
Event key
0
Event type
3
Date of event
2018-12-16
Date received
2020-03-31
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
TONI O'DOHERTY
Address
PARKMORE BUSINESS PARK WEST GALWAY IE
Phone
91-91-0917
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RESOLUTE ONYX RXSTENT, CORONARY, DRUG-ELUTINGMEDTRONIC IRELANDNIQRONYX25018X0008993336* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H

Event Narratives#

No narrative records found.