FDA.reportPublic FDA data

MAUDE MDR 5032733

MDR report key
5032733
Report number
3005841068-2015-00008
Event key
0
Event type
3
Date of event
2015-04-30
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-2226ASPIDE MEDICALOXJTINTRA E-2226TINTRA E-2226F09288AI N

Patients#

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

Event Narratives#

D

Patient 1

FOLLOWING REMOVAL OF PREVIOUSLY PLACED MESH AND RE-REPAIR OF A VENTRAL HERNIA USING SURGIMESH XB E-2226 DURING A ROBOTIC LAPAROSCOPIC, THE PATIENT WAS DIAGNOSED WITH PNEUMOPERITONEUM ON (B)(6) 2015. AT RE-EXPLORATION THE PATIENT WAS FOUND TO HAVE A TRANSVERSE COLON ENTEROTOMY WHICH WAS REPAIRED AND TREATED WITH CIPRO/FLAGYL AND A WOUND VAC. ON POD 3 THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR AN I AND D WITH INTERMEDIATE CLOSURE PERFORMED. ON POD 8 THE PATIENTS WOUND VAC WAS TAKEN DOWN AND THE ABDOMINAL WOUND PACKED WITH AQUACEL AND COVERED WITH GAUZE. ON POD 9 THE PATIENT WAS TRANSFERRED TO THE SAR WHERE HER VITAL SIGNS WERE STABLE. WOUND TREATMENT CONTINUES WITH THE XB E-2226 IN PLACE. STERILITY OF THE XB E-2226 WAS CONFIRMED WITH THE MANUFACTURERS STERILIZATION RECORDS.