GALAFLEX LITE

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4) THE SUBJECT PATIENT UNDERWENT SURGERY ON (B)(6) 2025 DURING WHICH A GALAFLEX LITE WAS PLACED. ON (B)(6) 2026, THE SUBJECT PATIENT WAS DIAGNOSED WITH RIGHT BREAST TENDERNESS AND TIGHTNESS. IT WAS ALSO REPORTED THAT THE DOCTOR PRESCRIBED PROPHYLACTIC ANTIBIOTIC (LINEZOLID) 600 MG BID FOR 7 DAYS. RIGHT BREAST ULTRASOUND WAS PERFORMED AND RESULT WAS NORMAL. THE REPORTED ADVERSE EVENTS (RIGHT BREAST TENDERNESS AND TIGHTNESS) HAVE BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLE RELATED TO THE PROCEDURE AND RECOVERING/RESOLVING. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, PATIENT WAS DIAGNOSED WITH RIGHT BREAST TENDERNESS AND TIGHTNESS POST IMPLANT OF GALAFLEX LITE. THE CLINICIANS HAVE ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLY RELATED TO THE PROCEDURE AND RECOVERING/RESOLVING. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THE LOT WAS MANUFACTURED TO SPECIFICATION. PAIN IS LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. 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.