FDA.reportPublic FDA data

MAUDE MDR 9186118

MDR report key
9186118
Report number
3005099803-2019-04997
Event key
0
Event type
3
Date of event
2019-09-18
Date received
2019-10-14
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
CAROLE MORLEY
Address
300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FUSE FULL SPECTRUM ENDOSCOPY SYSTEMENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENTBOSTON SCIENTIFIC CORPORATIONPEALS-FSC330-A6334600930000700234Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-140

Event Narratives#

No narrative records found.