FLOSEAL MATRIX HEMOSTATIC SEALANT

Description of Event or Problem

PT A: ACCORDING TO THE REPORTER: A GYN SURGEON AT HOSP CIRCULATED AN EMAIL TO HER COLLEAGUES ASKING THEM IF THEY HAD SEEN ANY INCIDENCE OF TUBAL OVARIAN ABSCESS IN THEIR POSTOPERATIVE OVARIAN CYSTECTOMY PTS, IN WHOM THEY HAD USED FLOSEAL. THE SURGEON HAD SEEN 2 IN THE PAST FEW DAYS/WEEKS AND WAS LOOKING FOR ADDITIONAL EXPERIENCES. REPORTER DID NOT HAVE ANY PT INFO TO SHARE AND ASSURED ME THAT, IN HER OPINION, THIS WAS NOT A SERIOUS SITUATION. BAXTER RN , ASKED REPORTER TO NOTIFY THE SURGEON THAT SHE HAD SPOKEN TO HER AND THAT BAXTER WAS VERY INTERESTED IN OBTAINING ADDITIONAL INFO. REPORTER ASSURED BAXTER RN THAT SHE WOULD SPEAK TO THE SURGEON AND TELL HER OF BAXTER'S RESPONSIVENESS AND INTEREST IN THIS CONCERN.

Additional Manufacturer Narrative

BAXTER MED DIR ASSESSMENT: FEBRUARY 14, 2007. FOR THE MEDICAL EVALUATION FOLLOWING CLINICAL DETAILS ARE REQUIRED. DIAGNOSIS AND INDICATION FOR SURGERY; POTENTIAL PERIOPERATIVE RISK FACTORS FOR INFECTION (DIABETES, INTRAOPERATIVE CONTAMINATION, DURATION OF SURGERY); COURSE AND OUTCOME OF INFECTION, INCLUDING CONFIRMATORY TESTS FOR ABSCESS; LOT NUMBER IN BOTH REPORTED CASES; SIMILAR ADVERSE EVENTS WITH THE SAME LOT NUMBER; APPLICATION METHOD: EXCESS OF FLOSEAL REMOVED OR NOT, VOLUME APPLIED. A MEDICAL CAUSALITY ASSESSMENT IS NOT POSSIBLE BASED ON THE EXISTING DATA. MULTIPLE ATTEMPTS HAVE BEEN MADE TO ACQUIRE ADDITIONAL INFO REGARDING THIS CASE WITH NO RESPONSE FROM THE NURSE. IF ANY FURTHER INFO COMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.