FDA.reportPublic FDA data

MAUDE MDR 8819477

MDR report key
8819477
Report number
2024168-2019-10277
Event key
0
Event type
3
Date of event
2019-06-28
Date received
2019-07-23
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CONNIE SPECK
Address
26531 YNEZ RD. TEMECULA CA 92591 US
Phone
951-951-9519
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RX HERCULINK ELITE STENT SYSTEMSTENT, RENALABBOTT VASCULARNIN1011492-127011661Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-07-230

Event Narratives#

No narrative records found.