GALAFLEX LITE

Additional Manufacturer Narrative

AS REPORTED, PATIENT DEVELOPED ERYTHEMA POST IMPLANT OF GALAFLEX LITE. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE ERYTHEMA AS CAUSALLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE AND NOT 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 ERYTHEMA AS POSSIBLE COMPLICATION. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. NOTE, THIS EVENT IS REPORTED FROM CLINICAL TRIAL (B)(6). 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)(6): ON (B)(6) 2025 - THE SUBJECT PATIENT UNDERWENT BREAST SURGERY DURING WHICH A GALAFLEX WAS PLACED IN BOTH BREASTS. ON (B)(6) 2025 - PATIENT WAS DIAGNOSED WITH BILATERAL RED BREAST SYNDROME, ERYTHEMA DIRECTLY OVERLIES MESH. IT WAS ALSO REPORTED THAT ANTIBIOTICS ARE NOT EFFECTIVE. THE REPORTED ADVERSE EVENTS (BILATERAL RED BREAST SYNDROME, ERYTHEMA) HAVE BEEN ASSESSED PER CLINICIAN AS A CASUAL RELATIONSHIP TO THE STUDY DEVICE, NOT RELATED TO THE PROCEDURE AND NOT RECOVERED/RESOLVED. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).