MalfunctionHAW
DISPOSABLE REFLECTIVE MARKER SPHERES
Received Jun 18, 2015
Report 3002743211-2015-00032 · MDR key 4852730
Device
Product problems
- Nonstandard Device
- Material Separation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY (B)(6) IN RESPONSE TO A RECALL NOTICE ISSUED FOR THE SAME MODEL OF SPHERES. AS NOTED BY THE COMPLAINANT: "THEY HAVE SPHERES BREAK APART ALL THE TIME GOING BACK TO LAST FALL." CUSTOMER/COMPLAINANT DID NOT PROVIDE ANY LOT NUMBERS, PICTURES OR WAS ABLE TO RETURN ANY DEFECTIVE DEVICES.