FDA.reportPublic FDA data

MAUDE MDR 9391601

MDR report key
9391601
Report number
2032227-2019-125320
Event key
0
Event type
3
Date of event
2019-11-07
Date received
2019-11-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
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
1630G INSULIN PUMP MMT-1715K 630G BLACK MGARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPENDMEDTRONIC PUERTO RICO OPERATIONS CO.OZOMMT-1715KMMT-1715KHG2KDXLR R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-290

Event Narratives#

No narrative records found.