InjuryOXJ
SURGIMESH
Received Aug 17, 2015 · Event occurred Jul 23, 2015
Report 3005841068-2015-00009 · MDR key 5057543
Device
Product problems
- Device Dislodged or Dislocated
Patient
21 YR
- Patient Problem/Medical Problem
Narrative
Description of Event or Problem
PATIENT RETURNED TO THE SURGEON AFTER GAINING (B)(6) SINCE PRIOR HERNIA REPAIR ON (B)(6) 2013, W/SIGNS OF BOWEL OBSTRUCTION AND WHAT LOOKED TO BE A LATERAL RECURRENCE. ON (B)(6) 2015, THE PREVIOUSLY PLACED SURGIMESH XB TINTRAL E-2226 WAS REMOVED AND REPLACED W/AN XB TINTRA E-3030 W/OUT CONSEQUENCE. THE XB E-2226 SHOWED NO SIGNS OF FAILURE EXCEPT THAT THE FIXATION TACKS HAD PULLED OUT OF THE ABDOMINAL WALL TISSUE IN PLACES. THE PATIENT RECOVERED UNEVENTFULLY.