FDA.reportPublic FDA data

MAUDE MDR 9392257

MDR report key
9392257
Report number
8010762-2019-00380
Event key
0
Event type
3
Date of event
2019-11-19
Date received
2019-11-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 RASTATT 76437 GM
Phone
497-497-4972
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OXYGENATOR WITH INTEGRATED HEAT EXCHANGEROXYGENATOR, CARDIOPULMONARY BYPASSMAQUET CARDIOPULMONARY GMBHDTZHMO 71000 #SQUADROX-I ADULT + FILTER70106782170126889N *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-300

Event Narratives#

No narrative records found.