FDA.reportPublic FDA data

MAUDE MDR 9392391

MDR report key
9392391
Report number
3004753838-2019-093922
Event key
0
Event type
3
Date of event
2019-10-25
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
MS ASHLEY SPOTO
Address
6340 SEQUENCE DR. SAN DIEGO CA 92121 US
Phone
858-858-8582
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMCONTINUOUS GLUCOSE MONITORDEXCOM, INC.PQF9438-06STT-MC-0017256861Y R

Patients#

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

Event Narratives#

No narrative records found.