MalfunctionOVN
DEK BL MF 0 TC-43/HR 26 2N 36"
Received Nov 11, 2015 · Event occurred Oct 30, 2015
Report 3004365956-2015-00341 · MDR key 5217223
Device
Product problems
- Break
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY RECORD OF BATCH NUMBER 74E1402012 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DEVICE SAMPLE WAS REPORTEDLY DISCARDED. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
ALLEGED EVENT: TWO METAL DARTS AT THE END OF THE SUTURES BROKE OFF INSIDE THE PATIENT AND THEY WERE NOT RETRIEVED. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.