GALAFLEX
Received Dec 24, 2025 · Event occurred Dec 9, 2025
Report 1213643-2025-01269 · MDR key 23887713
Device
Generic name
Breast - Absorbable Mesh
Manufacturer
Tepha, Inc. - 3005670760Model number
NACatalog number
UNKAA128
Lot number
NI
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
AS REPORTED, THE GALAFLEX MESH DID NOT ABSORB PROPERLY IN THE PATIENT.
Additional Manufacturer Narrative
AS REPORTED, GALAFLEX MESH DID NOT ABSORB PROPERLY IN A PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED UPON REQUEST. BASED ON THE LIMITED INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED THE IMPROPER ABSORPTION. A LOT NUMBER WAS NOT PROVIDED, AS SUCH A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. NOTE, THE EVENT DATE (09-DEC-2025) IS CONSIDERED TO BE A 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.