FDA.reportPublic FDA data

MAUDE MDR 5501638

MDR report key
5501638
Report number
3005473391-2016-00095
Event key
0
Event type
3
Date of event
2016-02-22
Date received
2016-03-15
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#

Contact
MR. JAMES BROOKS
Address
18109 NE 76TH STREET SUITE 100 REDMOND WA 98052 US
Phone
425-425-4253
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ESOPHYX2 HDODEENDOGASTRIC SOLUTIONS, INC.ODEC02042-01R2005NOT REPORTEDN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-1501. H

Event Narratives#

N

Patient 1

PROCEDURE WAS PERFORMED SUCCESSFULLY AND THE DEVICE WAS DISCARDED PER HOSPITAL POLICY. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. BLEEDING WAS NOT IDENTIFIED UNTIL PATIENT WAS BACK IN ROOM. POST OPERATIVE SCANS AND EXAM DID NOT REVEAL THE BLEEDING SITE, WHICH RESOLVED ON ITS OWN. THE PHYSICIAN REPORTED THE PATIENT WAS DOING WELL AND WAS RELEASED ON THE FOURTH DAY.

D

Patient 1

THE COMPANY SALES REP REPORTED THAT IN AN EMAIL CORRESPONDENCE WITH THE PHYSICIAN, IT WAS MENTIONED THE TIF PATIENT, WHO WOULD NORMALLY SPEND ONE NIGHT IN THE HOSPITAL FOLLOWING THE PROCEDURE, HAD SPENT SEVERAL MORE DAYS DUE TO BLEEDING. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS DISCARDED BY THE HOSPITAL AFTER THE SUCCESSFUL PROCEDURE. BLEEDING WAS IDENTIFIED AFTER THE PATIENT WAS BACK IN HER ROOM. POST PROCEDURE EXAMS/TESTING SHOWED NO FURTHER BLEEDING AND NO SPECIFIC BLEEDER SITE WAS FOUND. THE BLEEDING RESOLVED ON ITS OWN.