MalfunctionHAW
DISPOSABLE REFLECTIVE MARKER SPHERES
Received Aug 12, 2015
Report 3002743211-2015-00044 · MDR key 4994751
Device
Product problems
- Material Separation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING A CUSTOMER VISIT WITH A SALES REPRESENTATIVE, THE CUSTOMER ADVISED IN (B)(6) 2015 THAT A SPHERE SEPARATED A YEAR TO A YEAR AND A HALF AGO. CUSTOMER HOWEVER, HAS ONLY BEEN PURCHASING PRODUCT FROM (B)(6) 2015. DURING FOLLOW-UP, CUSTOMER COULD NOT RECALL ANY DETAILS OF THE EVENT AND COULD NOT PROVIDE ANY FURTHER INFORMATION OTHER THAN THE PRODUCT PROBLEM.