FDA.reportPublic FDA data

MAUDE MDR 8997647

MDR report key
8997647
Report number
2020394-2019-03252
Event key
0
Event type
3
Date of event
2019-05-28
Date received
2019-09-11
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
JUDITH LUDWIG
Address
1625 W 3RD ST. TEMPE AZ 85281 US
Phone
480-480-4803
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTRASCORE FOCUSED FORCE PTA BALLOONFOCUSED FORCE PTA BALLOONBARD PERIPHERAL VASCULAR, INC.PNOUS35130515US35130515GFCV3175R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-1101. R

Event Narratives#

No narrative records found.