Description of Event or Problem · 1
PELVIC ABSCESSES [PELVIC ABCESS]. CASE DESCRIPTION SPONTANEOUS REPORT REC'D: ON 16-OCT-2008, A PHYSICIAN REGARDING A FEMALE PT, AGE AND INITIALS UNK, WHO EXPERIENCED PELVIC ABSCESSES AFTER PLACEMENT OF SEPRAFILM. THE PT WAS IDENTIFIED BY THE MFR AS PT 1 OR 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, PT PRESENTED WITH SYMPTOMS RESULTING IN AN ADD'L EXPLORATORY SURGERY AND/OR HOSPITALIZATION. SHE WAS DIAGNOSED WITH A PELVIC ABSCESS. DUE TO THE PRESENCE OF THE CO-SUSPECT DRUG, MORPHINE, HE STATED HE WAS "UNSURE OF THE CAUSAL LINK TO THE USE OF HYDRATED SEPRAFILM". HE STATED THAT SHE HAD RECOVERED AND HAD BEEN DISCHARGED TO HOME.