Description of Event or Problem · 0
CASE (B)(4). THE PATIENT ASSOCIATED WITH THIS COMPLAINT UNDERWENT A SURGERY USING FLEXHD (PRE PECTORAL). IN (B)(6) 2020 THE PATIENT EXHIBITED A RED RIGHT BREAST ALONG WITH A SEROMA. DURING THE MONTH OF (B)(6) 2020, THE PATIENT WOUND BEGAN TO BREAKDOWN WHICH LED TO ASPIRATION OF THE WOUND. IN ADDITION TO ASPIRATING THE WOUND THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC (ERYTHROMYCIN). THE REDNESS CONTINUED FOR FOUR MONTHS, BUT THERE WAS NO SIGN OF A FEVER OR INFECTION. A SAMPLE WAS SENT FOR TESTING, AND ACCORDING TO THE INITIAL REPORTER; "NOTHING CAME BACK". DUE TO THE SERIES OF THESE EVENTS IN (B)(6) OF 2021 THE FLEXHD AND THE BREAST IMPLANT WAS REMOVED. MTF 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. MTF 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 MTF 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. INVESTIGATION: THE SERIAL NUMBER HAS NOT BEEN PROVIDED FOR THIS COMPLAINT; THEREFORE, AN INVESTIGATION HAS NOT BEEN CONDUCTED YET. FILED BY: (B)(6).