FDA.reportPublic FDA data

MAUDE MDR 9734715

MDR report key
9734715
Report number
8010762-2020-00072
Event key
0
Event type
3
Date of event
2020-01-29
Date received
2020-02-20
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
1HLM TUBING SET W/BIOLINE COATINGOXYGENATOR, CARDIOPULMONARY BYPASSMAQUET CARDIOPULMONARY GMBHDTZBEQ-HLS 7050 USA#HLS SET ADVANCED 7.070105279470135251Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2001. O

Event Narratives#

No narrative records found.