Description of Event or Problem · 1
PELVIC ABSCESSES [PELVIC ABSCESS]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED IN 2008 BY A PHYSICIAN REGARDING A FEMALE PATIENT, AGE AND INITIALS UNKNOWN, WHO EXPERIENCED PELVIC ABSCESSES AFTER PLACEMENT OF SEPRAFILM. THE PATIENT WAS IDENTIFIED BY THE MANUFACTURER AS PATIENT 2 OF 5. THE PHYSICIAN REPORTED THAT HE HAD USED AN (UNSPECIFIED) HYDRATED FORM OF SEPRAFILM IN THE INITIAL (UNSPECIFIED) SURGERY WHICH WAS DONE USING THE DAVINCI ROBOTIC DEVICE (THE PHYSICIAN STATED HE HAD PERFORMED 85 TOTAL ROBOTIC CASES USING THE UNSPECIFIED HYDRATED SEPRAFILM FORMULATION). HE STATED THAT HE HAD ALSO BEGUN INJECTING MORPHINE INTO THE VAGINAL CUFF AT THE SAME TIME HE BEGAN USING THE HYDRATED SEPRAFILM. AT AN UNSPECIFIED TIME AFTER THE INITIAL SURGERY, PATIENT PRESENTED WITH SYMPTOMS RESULTING IN AN ADDITIONAL EXPLORATORY SURGERY AND/OR HOSPITALIZATION. SHE WAS DIAGNOSED WITH A PELVIC ABSCESS. DUE TO THE PRESENCE OF THE CO-SUSPECT DRUG, MORPHINE, THE PHYSICIAN STATED HE WAS "UNSURE OF THE CAUSAL LINK TO THE USE OF HYDRATED SEPRAFILM". HE STATED THAT THE PATIENT HAD RECOVERED AND HAD BEEN DISCHARGED TO HOME.