FDA.reportPublic FDA data

MAUDE MDR 9908734

MDR report key
9908734
Report number
3004464228-2020-04718
Event key
0
Event type
3
Date of event
2020-01-01
Date received
2020-03-31
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
JORDAN BISWURM
Address
100 NAGOG PARK ACTON MA 01720 US
Phone
978-978-9786
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OMNIPOD DASH? INSULIN MANAGEMENT SYSTEMPUMP, INFUSION, INSULININSULET CORPORATIONLZG18320BLE-I1-529R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H; 2. R

Event Narratives#

No narrative records found.