SURGIMESH XB
Received Aug 21, 2015 · Event occurred May 6, 2015
Report 3005841068-2015-00006 · MDR key 5032731
Device
Generic name
Tintra E-2226
Manufacturer
Bg MedicalModel number
TINTRA E-2226Catalog number
TINTRA E-2226
Lot number
F009288A
Product problems
- Contamination
Patient
21 YR
- Abscess
Narrative
Description of Event or Problem
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.