MalfunctionOVN
DEK BL MF 0 TC-43/HR 26 2N
Received Jul 29, 2015 · Event occurred Jul 3, 2015
Report 3004365956-2015-00197 · MDR key 4950516
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ALLEGED EVENT: THE SUTURE BROKE DURING BENDING. THE PATIENT'S CONDITION WAS REPORTED AS RECOVERING.
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY OF BATCH NUMBER (B)(4) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.