Description of Event or Problem · 1
ANTERIOR CERVICAL SWELLING [LOCAL SWELLING]. MAJOR INFLAMMATORY REACTION/GRANULOMA (POSITIVE HISTOPATHOLOGY) [GRANULOMA]. CASE DESCRIPTION. A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2010, FROM A HEALTHCARE PROVIDER (HCP) AND A REGULATORY AGENCY REGARDING A FEMALE PT, AGE AND INITIALS UNK, WHO EXPERIENCED ANTERIOR CERVICAL SWELLING AND INFLAMMATORY REACTION AFTER TREATMENT WITH SEPRAFILM. THE PT UNDERWENT A TOTAL THYROIDECTOMY ON (B)(6) 2010. AT THE END OF THE PROCEDURE, ONE UNIT OF SEPRAFILM WAS PLACED (LOT NUMBER 09NP197) ALONG WITH A HEMOSTATIC GAUZE. ON (B)(6) 2010, A SECOND SURGERY WAS PERFORMED BECAUSE THE PT PRESENTED WITH ANTERIOR CERVICAL SWELLING. DURING THE PROCEDURE, A MAJOR LOCAL INFLAMMATORY REACTION WAS DISCOVERED. HISTOLOGY REVEALED THAT THERE WAS NO FOREIGN BODY AND THAT THERE WERE SEVERAL MACROPHAGES. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2010, FROM THE HCP. THE PT WAS A (B)(6) FEMALE (B)(6). IT WAS REPORTED THAT THE PRE-OPERATIVE DIAGNOSIS FOR THE THYROIDECTOMY PERFORMED ON (B)(6) 2010, WAS BENIGN ADENOMA. THE HCP COMMENTED THAT THE NATURE OF THE CERVICAL SWELLING WAS A HARD, INFLAMMATORY TUMEFACTION, THAT WAS PAINFUL, HOT, AND RED. DURING THE SECOND SURGERY ON (B)(6) 2010, INFLAMMATORY TISSUE WAS REMOVED. THE PATHOLOGY REPORT CONCLUSION WAS: CUTANEOUS AND SUBCUTANEOUS MACROPHAGIC GRANULOMA UNDERGOING RESORPTION. NO SUPPURATION AND NO TUMOR. THE HCP REPORTED THAT THE EVENTS WERE SEVERE IN NATURE AND PROBABLY RELATED TO SEPRAFILM. AT THE TIME OF THIS REPORT, THE PT HAD NOT YET RECOVERED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.