FDA.reportPublic FDA data

MAUDE MDR 9794509

MDR report key
9794509
Report number
1037905-2020-00122
Event key
0
Event type
3
Date of event
2020-01-18
Date received
2020-03-05
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. SCOTTIE FARIOLE
Address
4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US
Phone
336-336-3367
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INSTINCT ENDOSCOPIC HEMOCLIPPKL, LIGATOR, HEMORRHOIDALCOOK ENDOSCOPYPKLG18343INSC-7-230-SW4281020Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-050

Event Narratives#

No narrative records found.