GALAFLEX LITE

Description of Event or Problem

AS REPORTED ON 01-FEB-2026, THE PATIENT UNDERWENT IMPLANT OF GALAFLEX LITE. POST TWO (2) WEEKS OF IMPLANTATION THE PATIENT HAD EXPERIENCED FULL BODY RASHES. REPORTEDLY, THE PATIENT HAD NO KNOWN ALLERGIES BEFORE. THE PATIENT WAS TREATED WITH TOPICAL OINTMENTS AND STEROIDS WITH NO RESOLUTION OF THE RASH. THE PATIENT UNDERWENT REACTIVITY TESTING WITH THE PROVIDED GALAFLEX SAMPLE. THE REACTIVITY TEST WAS NEGATIVE, AND THE PATIENT HAD NO SENSITIVITIES TO ANY OF THE SURGICAL PRODUCTS TESTED. AS PER THE ALLERGIST, THEY WILL ATTEMPT TESTING OF THE SILICONE IMPLANT MATERIAL AS THIS WAS THE LAST MATERIAL TO BE TESTED.

Additional Manufacturer Narrative

AS REPORTED, A PATIENT WAS IMPLANTED WITH GALAFLEX LITE, POST TWO (2) OF IMPLANTATION PATIENT HAD A FULL BODY RASH. REACTIVITY TESTING HAS BEEN PERFORMED AND AS REPORTED THE RESULTS WERE NEGATIVE FOR AN ALLERGIC RESPONSE TO THE GALAFLEX LITE SAMPLE. IT IS UNKNOWN AT THIS TIME, WHAT IS CAUSING THE PATIENT'S POSTOPERATIVE RASHES. HOWEVER, BASED ON TESTING PERFORMED THE POSTOPERATIVE CONDITIONS EXPERIENCED BY THE PATIENT DO NOT APPEAR TO BE CAUSED BY THE GALAFLEX LITE USED TO TREAT THE PATIENT. REVIEW OF MANUFACTURING RECORDS CONFIRMS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. THE ADVERSE REACTION SECTION IN IFU STATES, "IN PRE-CLINICAL TESTING, THE GALAFLEX LITE SCAFFOLD ELICITED A MINIMAL TISSUE REACTION CHARACTERISTIC OF FOREIGN BODY RESPONSE TO A SUBSTANCE. THE TISSUE REACTION RESOLVED AS THE SCAFFOLD WAS ABSORBED." 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.