FDA.reportPublic FDA data

MAUDE MDR 8808078

MDR report key
8808078
Report number
3005162618-2019-00030
Event key
0
Event type
3
Date of event
2019-06-19
Date received
2019-07-19
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
1GRANUFLO 2251 2K 2.5CA 1MG 16.5 GALDIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)OREGON MANUFACTURING PLANTKPO0FD2251-3B19DXGF022R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-07-1920081. R

Event Narratives#

No narrative records found.