FDA.reportPublic FDA data

MAUDE MDR 8922738

MDR report key
8922738
Report number
2182208-2019-01542
Event key
0
Event type
3
Date of event
2019-08-01
Date received
2019-08-22
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
PAULA BIXBY
Address
8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ATTAIN VENOGRAM BALLOON CATHETERCATHETER, FLOW DIRECTEDMEDTRONIC, INC.DYG621562150061660449Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-08-220

Event Narratives#

No narrative records found.