INTELLIVUE NMT HAND-ADAPTER

Description of Event or Problem

IT WAS REPORTED THE PATIENT DEVELOPED A PRESSURE ULCER AT THE BASE OF THE THUMB AND INDEX FINGER DUE TO THE NMT HAND ADAPTOR. AFTER A PROLONGED SURGERY OF APPROXIMATELY 8 HOURS, THE PATIENT'S FINGER BECAME RED AND PAINFUL. AFTER ONE DAY, THE PAIN HAD SUBSIDED, BUT THE REDNESS REMAINED, AND THE PATIENT WAS DIAGNOSED WITH A PRESSURE ULCER, LOCATED AT THE BASE OF THE THUMB AND INDEX FINGER. IT WAS UNKNOWN IF ANY TREATMENT WAS REQUIRED TO TREAT THE PRESSURE ULCER.

Additional Manufacturer Narrative

PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative

THE ISSUE HAS BEEN REVIEWED AND IT HAS BEEN DETERMINED THAT THE REPORTED EVENT IS NOT REPORTABLE. THE PATIENT'S HANDS WERE IN ONE POSITION IN SUCH A WAY THAT THEY INTERFERED WITH EACH OTHER, WHICH MAY HAVE RESULTED ON PRESSURE ON HANDS, WITH SUBSEQUENT PRESSURE ULCERS. IT WAS INDICATED THE PATIENT WAS SEEN ONE WEEK LATER BY A DERMATOLOGIST, WHO PRESCRIBED A HEPARIN ANALOG OIL-BASED CREAM TO REDUCE REDNESS. THE ULCER RESOLVED WITH NO PERMANENT IMPAIRMENT. IMAGES WERE REVIEWED, REVEALING REDNESS AT THE BASE OF THE RIGHT THUMB AND INDEX FINGER WITH NO ADDITIONAL SKIN BREAKDOWN NOTED. BASED ON THIS INFORMATION, THE REPORTED HARM DOES NOT MEET THE DEFINITION OF SERIOUS INJURY AT THIS TIME. IN ADDITION, IT SHOULD BE NOTED THE HEPARIN CREAM PRESCRIBED CAN ALSO BE PURCHASE OVER THE COUNTER.