FDA.reportPublic FDA data

MAUDE MDR 8772066

MDR report key
8772066
Report number
3010119152-2019-00001
Event key
0
Event type
3
Date of event
2019-06-13
Date received
2019-07-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
2801 LAKESIDE DR., SUITE 210 BANNOCKBURN IL 60015 US
Phone
847-847-8472
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIESFIBER OPTIC DIFFUSERPINNACLE BIOLOGICS, INC.MVGDCYL200DCYL2505844401R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-07-0901. R

Event Narratives#

No narrative records found.