GALAFLEX LITE
Received Apr 13, 2026 · Event occurred Mar 25, 2026
Report 1213643-2026-00501 · MDR key 24857772
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
- Hematoma
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
AS REPORTED, PATIENT DEVELOPED SWELLING AND HEMATOMA POST IMPLANT OF GALAFLEX LITE. THE CLINICIAN HAS ASSESSED THE PATIENT'S POSTOPERATIVE HEMATOMA AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY 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 REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS HEMATOMA 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 WAS PLACED. ON (B)(6) 2026 - PATIENT WAS DIAGNOSED WITH HEMATOMA IN RIGHT BREAST AND DRAINAGE WAS PERFORMED, PATIENT PRESENTED WITH SWELLING IN RIGHT BREAST. FULLNESS/FLUCTUANCE ON LAT ASPECT OF IMF INCISION.140 CC OF DARK HEMATOMA ASPIRATED. THE REPORTED ADVERSE EVENT (DRAINAGE HEMATOMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSAL 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 SERIOUS ADVERSE DEVICE EVENT).