FDA.reportPublic FDA data

MAUDE MDR 9392222

MDR report key
9392222
Report number
2032227-2019-125377
Event key
0
Event type
3
Date of event
2019-09-10
Date received
2019-11-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
GERWIN DE GRAAFF
Address
CEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777
Phone
818-818-8185
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PUMP MMT-1780KPK 670G PATHWAY BLACK MGARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROLMEDTRONIC PUERTO RICO OPERATIONS CO.OZPMMT-1780KPKMMT-1780KPKHG1X11ZR R

Patients#

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

Event Narratives#

No narrative records found.