Description of Event or Problem · 1
ABSCESS AT THE CESAREAN SECTION SURGICAL SITE WHERE SEPRAFILM HAD BEEN PLACED [ABDOMINAL ABSCESS]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010, FROM A PHYSICIAN VIA A COMPANY REPRESENTATIVE REGARDING AN "APPROXIMATELY" (B)(6) FEMALE PT, INITIALS UNKNOWN, WITH A RELEVANT MEDICAL HISTORY OF A PRIMARY CESAREAN SECTION. APPROXIMATELY 10 DAYS AGO, THE PATIENT UNDERWENT A PRIMARY CESAREAN SECTION DURING WHICH SEPRAFILM WAS PLACED. ON AN UNK DATE, AFTER PLACEMENT OF SEPRAFILM, THE PATIENT DEVELOPED AN ABSCESS AT THE CESAREAN SECTION SURGICAL SITE WHERE THE SEPRAFILM HAD BEEN PLACED. THE ABSCESS HAS BEEN DRAINED AND SAMPLES HAVE BEEN SUBMITTED FOR LABORATORY ASSESSMENT. AS OF THE DATE OF THE REPORT, THE RESULTS OF THE LABORATORY ASSESSMENT WERE PENDING. NO FURTHER INFORMATION WAS PROVIDED. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT OUTCOME WAS UNK. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SEPRAFILM IS NOT AFFECTED BY THIS REPORT.