FDA.reportPublic FDA data

MAUDE MDR 9392007

MDR report key
9392007
Report number
8030665-2019-01819
Event key
0
Event type
3
Date of event
2019-11-11
Date received
2019-11-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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
1LIBERTY CYCLER SET, SINGLE CONN./EXT. DLSYSTEM, PERITONEAL, AUTOMATIC DELIVERYERIKA DE REYNOSA, S.A. DE C.V.FKX050-87216R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2901. H; 2. R

Event Narratives#

No narrative records found.