FDA.reportPublic FDA data

MAUDE MDR 9224322

MDR report key
9224322
Report number
8030665-2019-01633
Event key
0
Event type
3
Date of event
2019-10-15
Date received
2019-10-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MATTHEW AMARAL
Address
920 WINTER ST. WALTHAM MA 02451 US
Phone
781-781-7816
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CUSTOM COMBI SETSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVEERIKA DE REYNOSA, S.A. DE C.V.FJK03-2722-919JR01170R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-230

Event Narratives#

No narrative records found.