Description of Event or Problem · 0
(B)(4): RECEIVED REPORT FROM JOHNSON & JOHNSON MEDICAL (B)(4) ON 25-OCT-2018. SINCE STARTING TO RE-EVALUATE FLEXHD IN (B)(6) OF 2018, HE HAS HAD TWO OF FIVE PATIENTS GET RED BREAST. ONE OF WHICH HE REMOVED THE ADM TODAY, TO FIND THERE HAD BEEN NO TISSUE INTEGRATION. 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. AS PER MTFS MEDICAL DIRECTOR, DR. (B)(4), "COMPLAINT OF TWO OF FIVE PATIENTS WITH RED BREAST SYNDROME. IN ONE PATIENT, THE ADM WAS REMOVED AND THE GRAFT WAS FOUND NOT TO BE INTEGRATED. DESPITE MULTIPLE REQUESTS FOR FURTHER INFORMATION, INCLUDING SERIAL NUMBERS AND EVENT REPORTS, NOTHING FURTHER WAS RECEIVED. EMAILS TO THE IMPLANTING SURGEON DIRECTLY FROM THE MEDICAL DIRECTOR OF MTF ALSO WENT UNANSWERED. WITHOUT ESSENTIAL INFORMATION ON THE GRAFTS AND THE PATIENTS, THERE CAN BE NO FURTHER EVALUATION." FILED BY: (B)(4), MTF BIOLOGICS. BREAST RECONSTRUCTION.