FDA.reportPublic FDA data

MAUDE MDR 4240081

MDR report key
4240081
Report number
3004365956-2014-00383
Event key
0
Event type
3
Date of event
2014-09-05
Date received
2014-11-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JASMINE BROWN
Address
PO BOX 12600 RTP NC 27709 US
Phone
919-919-9193
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEKNATEL TEV TRI BR 2-0 KT-3 30"X9 PFMNEEDLETELEFLEX MEDICALOVNG79-114C9K02A1401018Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-040

Event Narratives#

D

Patient 1

COMPLAINT ALLEGES: IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT PROCEDURE, WHILE TYING THE STITCHES DOWN, THEY BROKE. THE SURGEON REPLACED THE SUTURES AND FINISHED THE CASE. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT IS IN STABLE CONDITION.

N

Patient 1

DEVICE HISTORY RECORD (DHR) SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO MANUFACTURER'S SPECIFICATIONS. DEVICE SAMPLE RECEIVED BY MANUFACTURER, BUT INVESTIGATION IS STILL UNDERWAY AT TIME OF THIS REPORT.