GALAFLEX LITE

Additional Manufacturer Narrative

AS REPORTED, PATIENT HAS EXPERIENCED PAIN AND DIAGNOSED WITH CELLULITIS IN RIGHT BREAST POST IMPLANT OF GALAFLEX LITE. THE CLINICIANS HAVE ASSESSED THE PATIENT'S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. HOWEVER, BASED ON THE INFORMATION PROVIDED THE DEGREE TO WHICH THE GALAFLEX LITE IMPLANT USED TO TREAT THE PATIENT, MAY HAVE CAUSED, OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE IS UNKNOWN. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE IDENTIFIES INFECTION AND PAIN AS POSSIBLE COMPLICATIONS. REGARDING INFECTION, THE PRECAUTION SECTION OF IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION TO RESOLUTION. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE SCAFFOLD." A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. NOTE, THIS EVENT IS REPORTED FROM CLINICAL TRIAL (B)(4). THE PRODUCT NUMBER GFLT0025IDE AND REPORTED LOT LXKV0017 WAS MADE EXCLUSIVELY FOR USE IN THE CLINICAL TRIAL. THE PRODUCT IS NOT FOR GENERAL COMMERCIAL USE. THE PRODUCT CODE (GFLT0025IDE) IS A "SIMILAR DEVICE" TO GFLT0025 (GALAFLEX LITE). AS SUCH THERE IS NO UDI INCLUDED. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4). ON (B)(6) 2026 - THE SUBJECT PATIENT WAS IMPLANT WITH GALAFLEX LITE. ON (B)(6) 2026 - THE PATIENT REPORTED ERYTHEMA AND INCREASED PAIN AROUND THE DRAIN SITE ON THE LATERAL RIGHT BREAST. ON EXAMINATION, RIGHT BREAST CELLULITIS WAS DIAGNOSED. THE PATIENT WAS STARTED ON AUGMENTIN. SHE WAS ADVISED TO APPLY BACITRACIN TO THE DRAIN SITE TWICE DAILY AND TO CLEAN THE AREA WITH HIBICLENS. THE REPORTED ADVERSE EVENT (RIGHT BREAST CELLULITIS) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT).