FDA.reportPublic FDA data

MAUDE MDR 9391972

MDR report key
9391972
Report number
2134265-2019-14621
Event key
0
Event type
3
Date of event
2019-08-29
Date received
2019-11-29
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
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROMUS ELEMENT PLUSSTENT, CORONARY, DRUG-ELUTINGBOSTON SCIENTIFIC CORPORATIONNIQ938493840022626440Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-290

Event Narratives#

No narrative records found.