Description of Event or Problem · 0
CASE (B)(4): THIS WAS REPORTED AS PART OF A STUDY SPONSORED BY (B)(6). THE EXTERNAL SITE ENTERED IT INTO THE STUDY DATABASE ON 1/2/2019. "DESCRIPTION OF WOUND SITE: (B)(6) 2018: MILD ECCHYMOSIS TO THE BREASTS BILATERALLY. THERE IS A SMALL DUSKY AREA AT THE MIDDLE OF THE RIGHT BREAST, APPROXIMATELY THE SIZE OF A QUARTER, (B)(6) 2018: THE RASH HAS EXTENDED BEYOND THE AXILLARY LINE OVER EACH BREAST; (B)(6) 2018: 30 CC OF SEROMA FLUID WAS REMOVED FROM RIGHT BREAST. REDNESS HAS SUBSIDED ON BILATERAL BREASTS; (B)(6) 2018: 40 CC OF SEROMA FLUID WAS REMOVED FROM RIGHT BREAST; (B)(6) 2018: NO SEROMA NOTED AT THIS TIME. (B)(6) 2018: PATIENT HAS TWO SCABS ON THE RIGHT BREAST, ONE OF WHICH HAS MILD DRAINAGE. NO TISSUE EXPANDER VISIBLE. (B)(6) 2018: A 1X1 CM AREA ON THE RIGHT BREAST IS OPEN WHERE IT APPEARS A SCAB HAS FALLEN OFF. PA WILL SUTURE THE AREA; (B)(6) 2018: THE SUTURES TO THE RIGHT BREAST WERE REMOVED TODAY. SERIAL NUMBERS: (B)(4) (ADM LATERALITY NOT SPECIFIED). (B)(6) DOES NOT ROUTINELY REPORT NOR IS IT REQUIRED TO REPORT COMPLAINTS BASED SOLELY UPON A COMPLAINT OF RBS INCLUDING ERYTHEMA, SWELLING AND/OR INFLAMMATION AND THE USE OF FLEXHD/BELLADERM BECAUSE THESE REPORTS DO NOT RELATE TO COMMUNICABLE DISEASE TRANSMISSION PURSUANT TO THE REPORTING REQUIREMENTS IN PART 1271. (B)(6) ACKNOWLEDGES THAT VOLUNTARILY SUBMITTING MEDWATCH REPORTS FOR CRITERIA THAT EXCEED THE REPORTING REQUIREMENTS AT 21 CFR § 1271.350(A), MAY PROVIDE USEFUL DATA FOR FDA AND INDUSTRY. HOWEVER, VOLUNTARILY REPORTING COMPLAINTS OF RBS INCLUDING ERYTHEMA, SWELLING AND/OR INFLAMMATION AND THE USE OF FLEXHD/BELLADERM THROUGH MEDWATCH UNDER 21 CFR PART 1271 DOES NOT MEAN OR CONSTITUTE ACKNOWLEDGEMENT IN ANY WAY THAT (B)(6) BELIEVES COMPLAINTS INVOLVING RBS POSES A RISK OF COMMUNICABLE DISEASE TRANSMISSION OR THAT FLEXHD OR BELLADERM AS HUMAN ADMS SHOULD BE REGULATED AS A MEDICAL DEVICE UNDER 21 CFR PARTS 807 (ESTABLISHMENT REGISTRATION) OR 820 (QUALITY SYSTEM REGULATIONS) AND RELATED MEDICAL DEVICE REGULATIONS, OR MEDICAL DEVICE REPORTING REQUIREMENTS UNDER 21 CFR PART 803. AS PER (B)(6) MEDICAL DIRECTOR, DR. (B)(6) ,COMPLAINT REPORTED AS PART OF CLINICAL STUDY PROTOCOL. (B)(6) WOMAN WITH IMMEDIATE BREAST RECONSTRUCTION POST MASTECTOMY USING ADM BILATERALLY. LATERALITY WAS NOT PROVIDED FOR GRAFT IMPLANTATION. 6 DAYS POST OP, THERE WAS MILD ECCHYMOSIS OR RASH BILATERALLY, WHICH THEN EXTENDED BEYOND AXILLARY LINE OVER EACH BREAST OVER NEXT 5 DAYS, AT WHICH TIME CLINDAMYCIN WAS PRESCRIBED. THIS RESOLVED, AND A TOTAL 70 CC OF SEROMA FLUID WAS REMOVED FROM RIGHT BREAST IN 2 ASPIRATIONS OVER FOLLOWING 2 WEEKS. SCABS FORMED ON THE RIGHT BREAST WITH MILD DRAINAGE, THEN HEALED. THE PATIENT HAD NO FEVER OVER THIS TIME PERIOD, AND NO WBC IS AVAILABLE. ON INVESTIGATION, THERE ARE NO OTHER COMPLAINTS ON GRAFTS RECOVERED FROM THIS DONOR. DONOR MET ALL CRITERIA, AND DERMIS STERILITY CULTURES NEGATIVE. NO LAL RESULT AVAILABLE. IN SUMMARY, MILD INFECTION IS POSSIBLE, AND STERILE INFLAMMATION FROM THE GRAFT COULD HAVE PLAYED A FACTOR, BUT THERE IS NO EVIDENCE OF INFECTION OR CROSS CONTAMINATION BY INFECTIOUS ORGANISMS FROM THE GRAFT. FILE BY: (B)(6). THERE WERE NO CULTURES PERFORMED ON THE PATIENT. BREAST RECONSTRUCTION.