FDA.reportPublic FDA data

MAUDE MDR 9371320

MDR report key
9371320
Report number
1037905-2019-00726
Event key
0
Event type
3
Date of event
2019-11-04
Date received
2019-11-25
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
1ACROBAT? CALIBRATED TIP WIRE GUIDEOCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGYCOOK ENDOSCOPYOCYG34266ACRO-35-450W4229975R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-250

Event Narratives#

No narrative records found.