Description of Event or Problem · 1
ALLERGIC REACTION [HYPERSENSITIVITY]. PERITONITIS [PERITONITIS]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011 FROM A PHYSICIAN VIA A COMPANY REPRESENTATIVE REGARDING A (B)(6) MALE PT. THE PT UNDERWENT A PROCEDURE DURING WHICH SEPRAFILM WAS USED. THE PT EXPERIENCED A PERITONITIS AND ALLERGIC REACTION ON (B)(6) 2011. THE PT WAS HOSPITALIZED ON AN UNK DATE IN 2011. FOR BOTH EVENTS, THE SEVERITY WAS SEVERE AND THE OUTCOME WAS NOT YET RECOVERED. AT THE TIME OF THIS REPORT, THE RELATIONSHIP WAS UNK. NO FURTHER INFO WAS PROVIDED. ADDITIONAL INFO WAS RECEIVED FROM THE PHYSICIAN ON (B)(6) 2011. ON (B)(6) 2011, THE PT HAD A LEFT HEMICOLECTOMY DUE TO DESCENDING COLON CANCER. DURING THE OPERATION, ONE SHEET OF SEPRAFILM, LOT NUMBER UNK, WAS PLACED UNDER THE ABDOMINAL WALL. THE CONCOMITANT MEDICAL DEVICES WERE BAG-DRAIN AND SINGLE USE STAPLER (PRODUCT NAME CEEA). ON (B)(6) 2011, A PERITONITIS AND ALLERGIC REACTION DEVELOPED AT THE WHOLE OF INTRA-ABDOMEN WHICH WAS THE AREA WHERE THE SEPRAFILM HAD BEEN PLACED. AS OF (B)(6) 2011, THE EVENTS WERE ONGOING. THE REPORTING SURGEON ASSESSED THE EVENTS AS SEVERE, SERIOUS, AND UNK RELATIONSHIP WITH SEPRAFILM. ADDITIONALLY, THE SUSPECTED THE PT'S OBESITY AND OTHER CONCOMITANT MEDICAL DEVICES AS CAUSALITIES. NO FURTHER INFO WAS PROVIDED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.