Description of Event or Problem · 1
COMPLICATIONS FROM THE SURGERY [POST PROCEDURAL COMPLICATION]. INFLAMMATORY RESPONSE [INFLAMMATION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011 RECEIVED FROM A SURGEON VIA A COMPANY SALES REPRESENTATIVE REGARDING A FEMALE PT, (AGE AND INITIALS UNK). APPROXIMATELY TWO YEARS AGO, THE PT HAD A COLON RESECTION DURING WHICH TWO TO THREE SHEETS OF SEPRAFILM WAS USED. THE SEPRAFILM LOT NUMBER WAS NOT AVAILABLE. THE PT HAD AN INFLAMMATORY RESPONSE AFTER THE SURGERY. FIFTEEN DAYS LATER, A SECOND SURGERY WAS PERFORMED. THE PT DIED OF COMPLICATIONS FROM THE SURGERY AND INFLAMMATION. NO FURTHER INFO WAS PROVIDED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011 FROM THE REPORTING SURGEON. THE INDICATION FOR THE SURGERY IN WHICH SEPRAFILM WAS USED WAS DIVERTICULOSIS. AN AUTOPSY WAS NOT PERFORMED. HE CONSIDERED THAT THE EVENTS OF COMPLICATIONS FROM THE SURGERY AND INFLAMMATION WERE DUE TO MULTI FACTORS. HE WAS NOT SURE IF THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE EVENTS AND SEPRAFILM. THE PHYSICIAN WAS NOT ABLE TO PROVIDE FURTHER INFO INCLUDING PT IDENTIFIERS, SEPRAFILM LOT NUMBER, SURGERY, EVENT ONSET DATES, AND PT'S MEDICAL HISTORY. NO FURTHER INFO WAS PROVIDED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.