Description of Event or Problem · 1
THIS WAS A SPONTANEOUS REPORT FROM A SURGEON VIA A SALES REPRESENTATIVE AND CONCERNS A (B)(6) FEMALE FROM THE UNITED STATES: (B)(4). INITIAL INFORMATION WAS PROCESSED WITH ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012. THE PATIENT'S HEIGHT, WEIGHT AND MEDICAL HISTORY WERE NOT REPORTED. THE PATIENT WAS TREATED WITH EVICEL (HUMAN CLOTTABLE PROTEIN/HUMAN THROMBIN, SOLUTION, TOPICAL) SPRAYED VIA OMRIX PRESSURE REGULATOR FOR HEMOSTASIS AFTER A LAPAROSCOPIC TOTAL HYSTERECTOMY (DATE OF USE AND DOSAGE UNSPECIFIED). THE SURGEON USED EVICEL AT A PREDEFINED PRESSURE ACCORDING TO INSTRUCTIONS FOR USE "IFU" AT A 4-6 CENTIMETER DISTANCE (EXACT PRESSURE NUMBERS NOT REPORTED). CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE SALES REPRESENTATIVE INITIALLY REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY THE PATIENT WENT INTO DEFIBRILLATION AND DIED. UPON FOLLOW-UP, THE SURGEON REPORTED THERE WAS OOZING BLEEDING AT THE VAGINAL CUFF AFTER THE HYSTERECTOMY. ABOUT 10-15 MINUTES AFTER THE EVICEL APPLICATION, WHEN THE SURGERY WAS ALMOST COMPLETED AND THE SKIN WOUND WAS ALREADY BEING CLOSED, THE ANESTHESIOLOGIST ALERTED THE SURGEON THE PATIENT WENT INTO CARDIAC ARREST. THE SURGEON REPORTED THAT HE DID NOT THINK THERE WAS AN AIR EMBOLISM AND CAUSE OF DEATH WAS UNKNOWN. A PATHOLOGY REPORT WAS EXPECTED. THE ACTION TAKEN WITH HUMAN CLOTTABLE PROTEIN/HUMAN THROMBIN WAS NOT APPLICABLE. THE PATIENT DIED FROM CARDIAC ARREST ON AN UNSPECIFIED DATE. THIS REPORT WAS SERIOUS (DEATH) AND REPORTABLE (DEATH AND SERIOUS INJURY). (B)(4).