inforMED
InjuryOOD

GALAFLEX 3D

Received Feb 19, 2026 · Event occurred Jan 27, 2026

Report 1213643-2026-00185 · MDR key 24388473

Device

Generic name

Breast - Absorbable Mesh

Model number

NI

Catalog number

UNKAA129

Lot number

NI

Product problems

  • Patient-Device Incompatibility

Patient

NA · Female

  • Hypersensitivity/Allergic reaction

Narrative

Additional Manufacturer Narrative

AS REPORTED, PATIENT PRESENTING WITH "ALLERGIC SYMPTOMS SINCE HER SURGERY" WITH GALAFLEX. BASED ON THE INFORMATION AVAILABLE TO DATE, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE GALAFLEX IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE ALLERGIC SYMPTOMS. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. ADDENDUM: H11: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED. THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT THE MEDICAL DEVICE BRAND NAME, MEDICAL DEVICE CATALOG AND PMA/ 510 (K) NUMBER. UPDATED FIELDS: B4, E1, G3, G6, H2, H10, H11. CORRECTED FIELD : D1 (MEDICAL DEVICE BRAND NAME), D4 (MEDICAL DEVICE CATALOG), G4 (PMA / 510(K)). 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, THE PATIENT IS PRESENTING WITH ALLERGIC SYMPTOMS SINCE HER SURGERY WITH GALAFLEX IMPLANT.

Additional Manufacturer Narrative

AS REPORTED, PATIENT PRESENTING WITH "ALLERGIC SYMPTOMS SINCE HER SURGERY" WITH GALAFLEX. BASED ON THE INFORMATION AVAILABLE TO DATE, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE GALAFLEX IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE ALLERGIC SYMPTOMS. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. 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, THE PATIENT IS PRESENTING WITH ALLERGIC SYMPTOMS SINCE HER SURGERY WITH GALAFLEX IMPLANT.