Description of Event or Problem · 1
PELVIC PAIN [SLURRY] [PELVIC PAIN]. ACUTE PERITONITIS [SLURRY] [PERITONITIS]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 08-APR-2008 FROM A PHYSICIAN VIA AN OUTSIDE COMPANY REPRESENTATIVE REGARDING A FEMALE PATIENT (INITIALS AND AGE UNKNOWN) WHO HAD AN UNKNOWN RELEVANT MEDICAL HISTORY. "SOMETIME IN THE LAST 6 MONTHS" (EXACT DATES NOT REPORTED), THE PATIENT UNDERWENT A RETROPERITONEAL DISSECTION WITH PARTIAL OMENTECTOMY AND LEFT OOPHORECTOMY, IN WHICH THE HCP LAPAROSCOPICALLY USED 5ML OF FLOSEAL ALONG WITH A SEPRAFILM "SLURRY" (# OF SEPRAFILM SHEETS USED NOT REPORTED). HE DID NOT RINSE AWAY OR IRRIGATE THE EXCESS FLOSEAL. AFTER THE INITIAL SURGERY, THE PATIENT DEVELOPED SIGNS OF AN INFECTION AND "REQUIRED RE-OPERATION DUE TO PELVIC PAIN." THE PHYSICIAN REPORTED, THAT THE PATIENT HAD "DIFFUSE INFLAMMATION" AT THE SITES OF SEPRAFILM AND FLOSEAL APPLICATION AND UNDERWENT AN EXPLORATORY OPERATION WHICH REVEALED ACUTE PERITONITIS. THE PHYSICIAN STATED, THAT HE "COULD NOT FIND AN EXPLANATION FOR THE ACUTE PERITONITIS". THE OUTSIDE COMPANY REPRESENTATIVE INFORMED THE HCP OF THE RECOMMENDATION OF THE FLOSEAL IFU - "THAT ONCE BLEEDING HAS CEASED, EXCESS PRODUCT THAT IS NOT INCORPORATED INTO THE CLOT, SHOULD BE REMOVED BY GENTLE IRRIGATION." AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT OUTCOME WAS RECOVERED (RECOVERY DATE UNKNOWN).