FDA.reportPublic FDA data

MAUDE MDR 5032731

MDR report key
5032731
Report number
3005841068-2015-00006
Event key
0
Event type
3
Date of event
2015-05-06
Date received
2015-08-21
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#

Address
20925 PHEASANT TRAIL SUITE 100 DEER PARK IL 60010 US
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SURGIMESH XBTINTRA E-2226BG MEDICALOXJTINTRA E-2226TINTRA E-2226F009288AI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-2101. R

Event Narratives#

D

Patient 1

ON (B)(6) 2015 PATIENT HAD AN OPEN VENTRAL HERNIA REPAIR AND POST OPERATIVELY SHOWED NO BOWEL MOVEMENT WITH TACHYCARDIA AND ABDOMINAL PAIN. A CT SCAN SHOWED A FLUID COLLECTION BEHIND THE ABDOMINAL WALL. THE FLUID COLLECTION WAS DRAINED ON (B)(6) 2015 SHOWING PURULENT MATERIAL AND THE PATIENT WAS STARTED ON ORGANISM SPECIFIC ANTIBIOTICS. THE XB TINTRA E-2226 WAS CONFIRMED STERILE THROUGH REVIEW OF MANUFACTURER STERILIZATION RECORDS. ON (B)(6) 2015 A FOLLOW-UP CT SCAN SHOWED NO FURTHER FLUID COLLECTION BEHIND THE ABDOMINAL WALL. THE PATIENT WAS AMBULATING BY (B)(6) 2015 AND DISCHARGED WITH THEIR DRAIN IN PLACE.