GALAFLEX LITE
Received Apr 21, 2026 · Event occurred Apr 3, 2026
Report 1213643-2026-00540 · MDR key 24943387
Device
Generic name
Breast - Absorbable Mesh
Manufacturer
Tepha, Inc. - 3005670760Model number
100027-34IDECatalog number
GFLT0025IDE
Lot number
LXKV0017
Product problems
- Patient-Device Incompatibility
Patient
NA · Female
- Capsular Contracture
- Pain
Narrative
Additional Manufacturer Narrative
AS REPORTED, THE PATIENT WAS EXPERIENCING INCREASED PAIN IN THE RIGHT BREAST POST IMPLANT OF GALAFLEX LITE. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE PAIN AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLY RELATED TO THE PROCEDURE. 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 PAIN IS UNKNOWN. THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST PAIN 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 CLINICAL TRIAL (B)(4): ON (B)(6) 2026 - THE SUBJECT PATIENT UNDERWENT SURGERY DURING WHICH A GALAFLEX LITE WAS PLACED. ON (B)(6) 2026 - PATIENT WAS DIAGNOSED WITH RIGHT BREAST PAIN AND TOOK PERCOCET. PATIENT SLEPT ON HER SIDE THE NIGHT BEFORE, THEN WOKE UP WITH INCREASED PAIN IN R BREAST, TOOK PERCOCET, WHICH SHE HAD FROM SURGERY. NO SURGICAL PROBLEM FOUND ON EXAM. GAVE CELEBREX AND GABAPENTIN. THE REPORTED ADVERSE EVENT (PAIN) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLY RELATED TO THE PROCEDURE. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).