GALAFLEX LITE

Additional Manufacturer Narrative

AS REPORTED, PATIENT HAD EXPERIENCED REDNESS AND WARMTH (ERYTHEMA) IN LEFT BREAST POST IMPLANT OF GALAFLEX LITE. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE REDNESS AND WARMTH (ERYTHEMA) AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE AND RECOVERING/RESOLVING. 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 REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS ERYTHEMA AS A 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)(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 STANCE CLINICAL TRIAL (B)(4): (B)(6) 2026 - THE SUBJECT PATIENT UNDERWENT SURGERY DURING WHICH A GALAFLEX LITE WAS PLACED. (B)(6) 2026 - PATIENT HAD REDNESS AND WARMTH IN LEFT BREAST AND THE REDNESS WAS RESOLVED WITH 24 HOURS OF IV ABX, PATIENT IS CURRENTLY ON PO ANTIBIOTICS (CIPROFLOXACIN 500 MG PO BID X 10 DAYS. RECEIVED IV VANCOMYCIN 1 GRAM Q 12 HOURS AND CLINDAMYCIN 600 MG Q8 FOR 24 HOURS THE REPORTED ADVERSE EVENTS (REDNESS AND WARMTH) HAVE BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE AND RECOVERING / RESOLVING. THE ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).