INGENIA

Additional Manufacturer Narrative

PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

PHILIPS RECEIVED A REPORT INDICATING THAT A PATIENT DEVELOPED A BURN FOLLOWING A PELVIS/RECTUM SCAN PERFORMED USING A BODY COIL. THE PATIENT REPORTED THAT THE BURN OCCURRED DURING THE SCAN AND SUBSEQUENTLY DEVELOPED INTO BLISTERS OVERNIGHT. NO INFORMATION REGARDING THE SIZE OF THE BLISTERS WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REVIEW, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE WHETHER THE REPORTED HARM MEETS THE CRITERIA FOR A SERIOUS INJURY. DUE TO THIS LACK OF INFORMATION, THE POSSIBILITY OF A SERIOUS INJURY CANNOT BE EXCLUDED. THEREFORE, THE DECISION HAS BEEN MADE TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.