OtherHSS
DEROYAL
Received Jun 17, 2013 · Event occurred May 24, 2013
Report 3005225477-2013-00009 · MDR key 3190396
Device
Product problems
- Device Operates Differently Than Expected
- Torn Material
Patient
Not reported
- Complaint, Ill-Defined
Narrative
Description of Event or Problem
THE END USER REPORTED THAT THE TRACTION UNIT TORE APART WHILE THE PATIENT WAS IN TRACTION, CAUSING CABLE TO SNAP BACK INTO PATIENT'S FACE.
Additional Manufacturer Narrative
DESCRIBE EVENT OR PROBLEM: THE END USER REPORTED THAT THE TRACTION UNIT TORE APART WHILE THE PATIENT WAS IN TRACTION, CAUSING CABLE TO SNAP BACK INTO PATIENTS FACE. DEROYAL: THE REPORTED DEVICE IS NOT AVAILABLE FOR EVALUATION. THE INVESTIGATION IS IN PROCESS AND THE ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS CURRENT TIME.