NONE
Received Dec 20, 2012 · Event occurred Nov 29, 2012
Report 1056069-2012-00008 · MDR key 2890549
Device
Generic name
None
Manufacturer
InvivoProduct problems
- Human-Device Interface Problem
Patient
Not reported
- Laceration(s)
Narrative
Description of Event or Problem
AT START OF THE EXAMINATION, THE PATIENT POSITIONED HIS HEAD SIDEWAYS ON THE BOTTOM PART OF THE INVIVO NEURO VASCULAR COIL ON A PHILIPS ACHIEVA 1.5T SYSTEM. WHEN THE PATIENT LOWERED HIS HEAD, THE LEFT EYEBROW STRUCK THE COIL WHICH WAS STATIONARY ON THE PATIENT TABLE. PATIENT INJURY REQUIRED SOME STITCHES.
Additional Manufacturer Narrative
(B)(4). METHOD, RESULTS, CONCLUSION - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THE 510K NUMBER IS NOT KNOWN AT THIS TIME SINCE THE HOSPITAL HAS NOT PROVIDED THE MODEL NUMBER OF THE DEVICE.