Description of Event or Problem · 1
CALLER REPORTED THAT HER DAUGHTER EXPERIENCED SEVERE PAIN AND SWELLING IN THE ABDOMEN AND SWELLING IN THE VAGINAL AREA AFTER ADMINISTRATION OF ADEPT. ALMOST IMMEDIATELY AFTER SURGERY IN WHICH ADEPT WAS USED, THE PATIENT EXPERIENCED THE EVENTS. THE EVENTS ARE ONGOING AND HAVE NOT RESOLVED. BAXTER MEDICAL ASSESSMENT (17-JUN-2008): THE DESCRIBED REACTIONS ARE EXPECTED ADVERSE EVENTS, THAT ARE OUTLINED IN THE INSTRUCTIONS FOR USE OF ADEPT: "IN THE STUDY, THE MOST FREQUENTLY OCCURRING (REPORT INCIDENCE AS % OF NUMBER OF PATIENTS) TREATMENT-RELATED ADVERSE EVENTS BETWEEN SURGERIES WERE POST PROCEDURAL LEAKING FROM PORT SITES, LABIAL, VULVAR OR VAGINAL SWELLING AND ABDOMINAL DISTENSION." THE DESCRIBED EVENTS ARE RELATED TO THE USE OF ADEPT. NO ADDITIONAL INVESTIGATION OR MEASURES ARE REQUIRED. ADDITIONAL INFORMATION RECEIVED ON 18-JUN-2008 BY (ASSOCIATE DIRECTOR OF GLOBAL MEDICAL EDUCATION): THE FOLLOWING INFORMATION WAS RECEIVED THROUGH A TELEPHONE CONVERSATION BONNIE HAD WITH THE PATIENT'S MOTHER. INITIAL DATE OF SURGERY WAS THE PREVIOUS MONTH. A LAPAROSCOPIC EXCISION OF A DERMOID CYST OFF THE OVARY WAS PERFORMED AT THE HOSPITAL AND 1 LITER OF ADEPT WAS USED AS A POST-OPERATIVE INSTALLATE. THE SURGEON DID DISCUSS WITH THE PATIENT THAT THE USE OF ADEPT MAY CAUSE DISTENTION AND EDEMA POST OPERATIVELY. FIVE HOURS AFTER THE INSTALLATION OF ADEPT, THE PATIENT WAS EXPERIENCING SEVERAL ABDOMINAL PAIN WITH DISTENTION AND VULVAR SWELLING 6 - 8 TIMES IT'S NORMAL SIZE. ACCORDING TO THE MOTHER, SOME TEST WAS DONE BECAUSE THEY WERE CONCERNED THAT THE PATIENT MAY BE BLEEDING INTERNALLY AND THIS TEST WAS NEGATIVE. THE EDEMA DID TRACK DOWN THE PATIENT'S LEGS. BOTH THE EDEMA AND THE ABDOMINAL DISTENTION RESOLVED BY POST-OPERATIVE DAY 4. HOWEVER, THE PATIENT CONTINUED TO FEEL UNWELL AND HAVE A LOW GRADE TEMPERATURE. ON A WEEK LATER, THE PATIENT WAS ADMITTED TO A DIFFERENT HOSPITAL, WITH A HIGH TEMPERATURE AND ABDOMINAL PAIN. CT SCAN DEMONSTRATED INFLAMMATION AROUND THE APPENDIX AND THE PATIENT UNDERWENT AN APPENDECTOMY. THIS DID NOT RESOLVE THE PATIENT'S ABDOMINAL DISCOMFORT AND SHE HAS UNDERGONE A TOTAL OF 5 CT SCANS SINCE HER ORIGINAL SURGERY EARLY OF THE MONTH. THE SCANS SHOW INFLAMMATORY TISSUE WHICH THE PATIENT AND FAMILY HAVE BEEN TOLD PRESENTS LIKE HYDROCHLORIC ACID BURNS AND IS LIKELY CAUSED BY THE ADEPT, AND THAT THE APPENDECTOMY WAS PERFORMED UNNECESSARILY. ON TWENTY FIVE DAYS AFTER THE SURGERY, THE PATIENT WAS READMITTED TO HOSPITAL(FIRST), WHERE SHE HAD HER ORIGINAL SURGERY. HER ENTRY COMPLAINTS WHERE CONTINUED ABDOMINAL PAIN, CHRONIC LOW GRADE FEVER AND GENERAL MALAISE. SHE WAS KEPT IN HOSPITAL FOR 2 WEEKS ON HIGH DOSE ANTIBIOTICS.