FDA.reportPublic FDA data

MAUDE MDR 25341023

MDR report key
25341023
Report number
2029046-2026-01748
Event key
0
Event type
3
Date of event
2026-05-07
Date received
2026-05-31
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#

Contact
MR. HENRY BODEN
Address
31 TECHNOLOGY DR IRVINE CA 92618 US
Phone
949-949-9497
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
193468THERMOCOOL SMARTTOUCH SFCARDIAC ABLATION PERCUTANEOUS CATHETERBIOSENSE WEBSTER INCLPBD13480531767042LNR
288061THERMOCOOL SMARTTOUCH SFCARDIAC ABLATION PERCUTANEOUS CATHETERBIOSENSE WEBSTER INCLPBD13480531767042LNR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-05-310

Event Narratives#

No narrative records found.