GALAFLEX 3DR
Received Jul 10, 2026 · Event occurred Jun 26, 2026
Report 1213643-2026-00902 · MDR key 25780792
Device
Generic name
Breast - Absorbable Mesh
Manufacturer
Tepha, Inc. - 3005670760Model number
NICatalog number
UNKAA130
Lot number
NI
Product problems
- Patient-Device Incompatibility
Patient
NA · Female
- Rash
Narrative
Additional Manufacturer Narrative
AS REPORTED, SEVERAL WEEKS AFTER BREAST AUGMENTATION AND GALAFLEX 3DR IMPLANTATION, THE PATIENT DEVELOPED A RASH ON THE CHEST, ABDOMEN, AND ARMS. MULTIPLE ATTEMPTS HAVE BEEN MADE REQUESTING ADDITIONAL INFORMATION, HOWEVER THERE HAS BEEN NO RESPONSE TO DATE. BASED ON THE LIMITED INFORMATION AVAILABLE TO DATE, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE GALAFLEX 3DR IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE RASH. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (26-JUN-2026) IS CONSIDERED TO BE THE BEST ESTIMATE BASED ON THE DATE OF AWARENESS. 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, SEVERAL WEEKS AFTER BREAST AUGMENTATION AND GALAFLEX 3DR IMPLANTATION, THE PATIENT DEVELOPED A RASH ON THE CHEST, ABDOMEN, AND ARMS. AS PER THE PHYSICIAN, "I HAVE RULED OUT MEDS AND ONLY THING I CAN THINK OF IS A REACTION TO THE GRAFTS."