L-CLIP TRAY TAG FOR 45.692
Received Jul 12, 2013 · Event occurred Jun 14, 2013
Report 1045834-2013-02734 · MDR key 3222524
Device
Product problems
- Material Discolored
- Flaked
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING PRE-TESTING IT WAS OBSERVED THAT THE "COLOR WAS FLAKING OFF" OF THE LABELS ON THE ANEURYSM TRAY DEVICE. ACCORDING TO THE REPORT, THE USER OBSERVED THAT THERE WAS "BUBBLING" UNDER THE PAINT. THE REPORTER INDICATED THAT THE "PINK COLOR" SEEMED TO BE AFFECTED THE MOST. THE ACTUAL DEVICE WAS USED IN THE SCHEDULED SURGERY AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, ADVERSE EVENTS, OR MEDICAL INTERVENTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative
AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).