Description of Event or Problem · 1
ABDOMINAL PAIN [ABDOMINAL PAIN]. ILEUS [ILEUS]. FEVER [PYREXIA]. PERITONITIS [PERITONITIS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A PHYSICIAN REGARDING A FEMALE PT, (B)(6) WHO HAD AN ABDOMINAL TOTAL HYSTERECTOMY (ATH). THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNK DATE AT THE (B)(6) 2011, THE PHYSICIAN HAD APPLIED ONE SHEET OF SEPRAFILM DURING THE ATH. ON AN UNK DATE IN 2011, THE PT DEVELOPED ABDOMINAL PAIN, ILEUS, AND FEVER. UNDER THE IMPRESSION IF ILEUS WITH UNK CAUSES, THE PT VISITED THE PHYSICIAN AT THE HOSPITAL. THE PHYSICIAN PERFORMED A DIAGNOSTIC LAPAROSCOPY UNDER SUSPICION OF PERITONITIS. WHITE BLOOD CELL (WBC) AND NEUTROPHIL COUNTS WERE NOT PROVIDED AND THE PT ALSO WAS "POSITIVE" FOR PERITONEAL SIGN. DURING THE LAPAROSCOPY, YELLOW TO GRAY AND GLUE-LIKE SEPRAFILM WAS FOUND AND CLEANED AWAY. THE ABDOMINAL CULTURE WAS NEGATIVE. THE ACTION TAKEN WITH SEPRAFILM WAS NOT PROVIDED. THE PTS OUTCOME FOR THE EVENTS WAS REPORTED AS RECOVERED WITHOUT SEQUELAE AS THE PT WAS DISCHARGED UNEVENTFULLY ON (B)(6) 2011. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENTS WAS POSSIBLY RELATED. THE SEVERITY WAS MODERATE. MANUFACTURE'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.