FDA.reportPublic FDA data

MAUDE MDR 9659673

MDR report key
9659673
Report number
3012293198-2020-00008
Event key
0
Event type
3
Date received
2020-02-03
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#

Address
PO BOX 13398 RESEARCH TRIANGLE PARK, NC 27709 US
Phone
888-888-8888
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOTENE ORAL RINSE (UNSPECIFIED VARIANT)ORAL RINSESKIK CUSTOM PRODUCTSLFDUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0301. O

Event Narratives#

No narrative records found.