DEK BL MF 0 TC-43/HR 26 2N 36"
Received Aug 31, 2015 · Event occurred Aug 7, 2015
Report 3004365956-2015-00268 · MDR key 5042587
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY RECORD OF BATCH NUMBERS (74D1501897, 74F1400285 & 74L1402847) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
ALLEGED EVENT: AFTER A BULLET DETACHED AND FELL INSIDE THE PATIENT, THEY LOADED A SECOND POLYPRO SUTURE OUTSIDE THE PATIENT AND THE BULLET FELL OFF. A DIFFERENT POLYPRO SUTURE WAS USED TO COMPLETE THE CASE. THE PATIENT'S CONDITION WAS REPORTED AS STABLE.