MalfunctionOVN
DEK BL MF 0 TC-43/HR 26 2N 36"
Received Jan 28, 2016 · Event occurred Jan 1, 2016
Report 3004365956-2016-00099 · MDR key 5396862
Device
Product problems
- Break
- Break
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY REVIEW OF BATCH NUMBER 74C1501749 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER 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: THE SUTURE BROKE AND THE TAPER CUT WAS LEFT IN PATIENT.THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.