MalfunctionOVN
SYNETURE
Received Jul 30, 2019 · Event occurred Jul 11, 2019
Report 1219930-2019-04507 · MDR key 8843389
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, ON A THIGH LIFT PLASTICS PROCEDURE, 8-10 MINUTES INTO THE PROCEDURE USING THE SUBCUTANEOUS CLOSURE SUTURING TECHNIQUE, THE NEEDLE DETACHED FROM THE SUTURE AFTER TWO TO THREE PASSES. IT WAS STATED THAT FOUR SUTURES WERE OPENED AND THE SAME ISSUE OCCURRED. THE STRAND WERE TIED AND ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.