MAUDE MDR 50941448

MDR report key
50941448
Report number
1416980-2026-03054
Event key
0
Event type
3
Date of event
2026-09-25
Date received
2026-09-30
Adverse event
0
Product problem
1
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Address
25212 W. Illinois Route 120 Round Lake IL 60073 US
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
319556CLEARLINKSet, administration, intravascularBAXTER HEALTHCARE CORPORATIONFPA2N83712N8371R25F03017NY
418198CLEARLINKSet, administration, intravascularBAXTER HEALTHCARE CORPORATIONFPA2N83712N8371R25F03017NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-09-300

Event Narratives#

No narrative records found.