SURGIMESH XB
Received Aug 21, 2015 · Event occurred Apr 30, 2015
Report 3005841068-2015-00008 · MDR key 5032733
Device
Generic name
Tintra E-2226
Manufacturer
Aspide MedicalModel number
TINTRA E-2226Catalog number
TINTRA E-2226
Lot number
F09288A
Product problems
- Microbial Contamination of Device
Patient
21 YR
- Bacterial Infection
Narrative
Description of Event or Problem
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.