InjuryGAS
SURGIPRO 0 30 BLUE GS-21 103P
Received Dec 5, 2014 · Event occurred Oct 25, 2014
Report 9612501-2014-00440 · MDR key 4299997
Device
Product problems
- Break
Patient
Not reported
- Cardiac Arrest
Narrative
Additional Manufacturer Narrative
(B)(4). FOLLOW UP 01 SENT TO FDA ON 03/24/2015.
Additional Manufacturer Narrative
INITIAL REPORT SENT TO FDA ON 012/5/2014.
Description of Event or Problem
THE DOCTOR WAS PERFORMING AN EPIGASTRIC VENTRAL HERNIA REPAIR TO A (B)(6) YEAR OLD PATIENT. AFTER SEWING THE PATIENT, THE SUTURE BROKE CAUSING THE HERNIA TO BREAK AGAIN AND THE PATIENT HAD CARDIAC ARREST. HE RECOVERED FROM THE HEART FAILURE AND WAS OPERATED ON AGAIN. THE PATIENT IS RECOVERING WITH A GOOD EVOLUTION.