Description of Event or Problem · 1
MALE PATIENT EXPERIENCED A HEMATOMA WHILST PARTICIPATING IN THE ABOVE STUDY, AFTER A SELF-ADMINISTRED ABDOMINAL SUBCUTANIOUS INJECTION. THE PATIENT HAS PREVIOUS MEDICAL HISTORY OF HYPERTENSION, POSITIVE HYPERTROPHY, RIGHT HIP REPLACEMENT, AND SCARS TO BILATERAL THIGHS AND RIGHT LOWER ABDOMEN FROM A WORK RELATED CHEMICAL BURN INJURY. THE PATIENT WAS ALSO RECEIVING MULTIPLE MEDICATIONS CONCOMITANTLY. IN 01/2006 THE PATIENT COMMENCED TREATMENT WITH SUBCUTANEOUS ENFUVIRTIDE AT A DOSE OF 90 MG TWICE DAILY ADMINISTERED USING THE BIOJECT B2000 NEEDLE-FREE INJECTION DEVICE (NFID). ON 02/24/2006, THE PATIENT WAS REPORTED TO HAVE GONE TO THE GYM THE SAME DAY AND UPON HIS RETURN HOME NOTICED SWELLING IN THE RIGHT ADBOMINAL AREA AND FELT THAT HIS SCROTUM BECAME HEAVY AND DISCOLORED. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AS A RESULT AND WAS ADMITTED FOR FURTHER EVALUATION. IT WAS NOTED THAT THE PATIENT HAD NOT EXPERIENCED CHEST PAIN, ABDOMINAL PAIN, VOMITING, OR ANY OTHER MAJOR SYMPTOMS AFTER THE INJECTION. UPON ADMISSION, LABORATORY RESULTS REVEALED THAT THE PATIENT'S PT-INR WAS 12.7 (NO UNITS PROVIDED), PRO-THROMBIN TIME WAS 24.4 9NO UNITS PROVIDED), HEMOGLOBIN WAS 16.9 G/DL, AND HEMATOCRIT WAS 48.1 WHITE BLOOD CELL COUNT AND PLATELET COUNT WERE REPORTED TO BE NORMAL. CT SCAN OF THE ABDOMEN INDICATED INJURY TO THE INFERIOR EPIGASTIC ARTERY OR VEIN. THE SCAN ALSO SUGGESTED FLUID COLLECTION IN THE RIGHT LOWER ABDOMEN BUT DID NOT APPEAR TO BE RELATED TO THE FEMORAL ARTERY AND FEMORAL VEIN. THE ASSESSMENT WAS REPORTED AS HEMATOMA OF THE ABDOMINAL WALL STATUS POST SELF-INJECTION. NO TACHYCARDIA OR HYPOTENSION WAS REPORTED. ONE DAY AFTER ADMISSION, THE PATIENT WAS WALKING WITH NO SIGNS OF HYPOVOLAMIA AND ALTHOUGH HEMOGLOBIN COUNT HAND SLIGHTLY DECREASED OVERNIGHT, COAGULATION STUDIES WERE WITHIN NORMAL LIMITS. TWO DAYS AFTER ADMISSION, THE PATIENT'S HEMOGLOBIN COUNT WAS REPORTED AS 14.8 G/DL AND HE WAS DISCHARGED FROM HOSPITAL. ONE DAY LATER, THE PATIENT RETURNED TO THE CLINIC FOR ROUTINE PROTOCOL STUDY AT WHICH TIME DIGITAL PICTURES WERE OBTAINED AND SENT TO THE STUDY SPONSOR WHO IN TURN FELT THAT THE PATIENT SHOULD BE RE-HOSPITALISED FOR FURTHER EVALUATION THREE DAYS LATER THE PATIENT WAS HOSPITALISED AGAIN AND THE BIOJECT 2000 WAS CHANGED AS PER STUDY SPONSOR. FURTHER EVALUATION WAS PERFORMED AND CT SCAN OF THE ABDOMEN AND PELVIS WITH AND WITHOUT CONTRAST SHOWED 6 X 8 CM MASS IN THE RIGHT LOWER QUADRENT OF THE ABDOMINAL WALL. ABDOMINAL ULTRASOUND SHOWED MASS MEASURING 9.4X4.4X8.8 CM. THE PATIENT WAS DISCHARGED FROM HOSPITAL IN 03/2006 WITH NO CHANGES TO CONCOMITANT MEDICATIONS BUT WITH THE ADDITION OF ORAL HYDROCODONE/PARACETAMOL (VICODIN ES) TWO TABLETS AS NEEDED DAILY FOR PAIN. THE PATIENT'S ONLY COMPLAINT WAS REPORTED AS PAIN WHEN BENDING OVER. THE EVENT OF HEMATOMA WAS CONSIDERED SERIOUS DUE TO THE REQUIREMENT OF PATIENT HOSPITALISATION. AT THE TIME OF THE REPORT, THE EVENT OF HEMATOMA WAS PERSISTING AND TREATMENT WITH ENFUVIRTIDE WAS MAINTAINED BUT THE METHOD OF ADMINISTRATION POST HOSPITAL DISCHARGE WAS NOT REPORTED. THE STATUS OF THE INVESTIGATOR CONSIDERED THE EVENT TO BE RELATED TO A PROTOCOL RELATED PROCEDURE AND RELATED TO THE BIOJECT 2000 DEVICE AND UNRELATED TO ENFUVIRTIDE.