MAUDE MDR 9831396

MDR report key
9831396
Report number
1820334-2020-00609
Event key
0
Event type
3
Date of event
2020-03-05
Date received
2020-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. JENNIFER CANADA
Address
750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone
812-812-8123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FORMULA 418 RENAL BALLOON-EXPANDABLE STENTCOOK INCNING56611FOR418-18-80-6-1210169998R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-130

Event Narratives#

No narrative records found.