GALAFLEX LITE

Additional Manufacturer Narrative

AS REPORTED, PATIENT WAS DIAGNOSED WITH RIGHT BREAST SURGICAL SITE INFECTION POST IMPLANT OF GALAFLEX LITE. THE CLINICIANS HAVE ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE AND RECOVERED/RESOLVED. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE, WERE REVIEWED AND FOUND TO ADEQUATELY PROVIDE INSTRUCTIONS, WARNINGS, AND KNOWN RISKS ASSOCIATED TO THE USE OF THE DEVICE. INFECTION IS LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. PRECAUTION SECTION OF IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION TO RESOLUTION. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE SCAFFOLD." NOTE, THIS EVENT IS REPORTED FROM CLINICAL TRIAL (B)(4). THE PRODUCT NUMBER GFLT0025IDE AND REPORTED LOT LXJN0002 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. ADDENDUM: H11: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED TO DOCUMENT THE INITIAL REPORTER INFORMATION AND TO CORRECT THE COMMON DEVICE NAME. UPDATED FIELDS: B4, E1, E3, G3, G6, H2, H10, H11. CORRECTED FIELD: D.2A (COMMON DEVICE NAME). 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): (B)(6) 2025 - THE SUBJECT PATIENT UNDERWENT SURGERY DURING WHICH A GALAFLEX LITE WAS PLACED. (B)(6) 2025 - PATIENT WAS DIAGNOSED WITH RIGHT BREAST SURGICAL SITE INFECTION IT WAS OBSERVED ON CT, LATERAL CHEST WALL FAT STRANDING AND SKIN THICKENING (R>L). NO COLLECTIONS. BREAST SKIN CX +VE STAPH AUREUS. DRAINS REMOVED, ANTIBIOTICS BEGUN. DISCHARGED WITH ORAL CEPHALEXIN 500MG FOR 7 DAYS. THE REPORTED ADVERSE EVENT (RIGHT BREAST SURGICAL SITE INFECTION) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE AND RECOVERED/RESOLVED. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, PATIENT WAS DIAGNOSED WITH RIGHT BREAST SURGICAL SITE INFECTION POST IMPLANT OF GALAFLEX LITE. THE CLINICIANS HAVE ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE AND RECOVERED/RESOLVED. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE, WERE REVIEWED AND FOUND TO ADEQUATELY PROVIDE INSTRUCTIONS, WARNINGS, AND KNOWN RISKS ASSOCIATED TO THE USE OF THE DEVICE. INFECTION IS LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. PRECAUTION SECTION OF IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION TO RESOLUTION. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE SCAFFOLD." NOTE, THIS EVENT IS REPORTED FROM CLINICAL TRIAL (B)(4). THE PRODUCT NUMBER: GFLT0025IDE AND REPORTED LOT: LXJN0002 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) 2025 - THE SUBJECT PATIENT UNDERWENT SURGERY DURING WHICH A GALAFLEX LITE WAS PLACED. ON (B)(6) -2025 - PATIENT WAS DIAGNOSED WITH RIGHT BREAST SURGICAL SITE INFECTION. IT WAS OBSERVED ON CT, LATERAL CHEST WALL FAT STRANDING AND SKIN THICKENING (R>L). NO COLLECTIONS. BREAST SKIN CX +VE STAPH AUREUS. DRAINS REMOVED, ANTIBIOTICS BEGUN. DISCHARGED WITH ORAL CEPHALEXIN 500MG FOR 7 DAYS. THE REPORTED ADVERSE EVENT (RIGHT BREAST SURGICAL SITE INFECTION) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE AND RECOVERED/RESOLVED. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).