MalfunctionHAW
DISPOSABLE REFLECTIVE MARKER SPHERES
Received Jul 2, 2015 · Event occurred Jun 5, 2015
Report 3002743211-2015-00038 · MDR key 4888646
Device
Product problems
- Break
- Nonstandard Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY (B)(6) FROM (B)(6) HOSPITAL IN RESPONSE TO A RECALL NOTICE ISSUED FOR THE SAME MODEL OF SPHERES. AS NOTED BY THE COMPLAINANT, DURING A PROCEDURE SPHERES BROKE APART. THERE WAS NO REPORT OF ANY PATIENT/USER INJURY, DEATH OR SERIOUS DETERIORATION IN HEALTH. COMPLAINANT DISPOSED OF PRODUCT.