Description of Event or Problem · 1
SMALL BOWEL OBSTRUCTION [SLURRY] [SMALL INTESTINAL OBSTRUCTION] ADHESIONS [SLURRY] [ADHESION]. CASE DESCRIPTION. SPONTANEOUS REPORT RECEIVED ON (B)(6) 2008 FROM A PHYSICIAN, VIA A GENZYME COMPANY REPRESENTATIVE REGARDING A FEMALE, PATIENT, INITIALS AND AGE UNKNOWN, WITH AN UNKNOWN MEDICAL HISTORY. THE PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY DURING WHICH SEPRAFILM SLURRY WAS USED. FIVE DAYS LATER, THE PATIENT EXPERIENCED SMALL BOWEL OBSTRUCTION AND WAS REOPERATED ON (B)(6) 2008. ON THIS NIGHT, THE PATIENT WAS ALSO FOUND TO "FULL OF ADHESION". THE PATIENT WAS DISCHARGED ON (B)(6) 2008 AND "SHE WAS DOING BETTER." THE PHYSICIAN STATED THAT THERE "MIGHT HAVE BEEN A PROBLEM WITH THE SLURRY" AND THAT THE SCRUB TECHNICIANS WERE "CONFUSED" AND EACH TIME THEY "MIX A DIFFERENT FORMULA." THE RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENTS WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE SMALL BOWEL OBSTRUCTION WAS NOT YET RECOVERED AND THE EVENT OF ADHESIONS WAS UNKNOWN. THE SEPRAFILM LOT NUMBER WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. SEE MANUFACTURER CONTROL NUMBER (B)(4) FOR OTHER ADVERSE EVENTS FROM THIS SOURCE. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.