GALAFLEX
Received Nov 20, 2024 · Event occurred Oct 30, 2024
Report 1213643-2024-00558 · MDR key 20733137
Device
Generic name
Absorbable Mesh
Manufacturer
Tepha, Inc. - 3005670760Model number
NICatalog number
UNKAA128
Lot number
NI
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Female
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
AS REPORTED, PRIOR IMPLANT OF GALAFLEX "HURT" THE PATIENT IN HER FIRST BREAST SURGERY. THE INFORMATION OBTAINED AT THIS TIME IS LIMITED AS NO ADDITIONAL INFORMATION HAS BEEN PROVIDED UPON REQUEST. THE REPORTING SURGEON DOES NOT HAVE MORE INFORMATION TO PROVIDE AS THEY WERE NOT THE ORIGINAL SURGEON WHO DID THE FIRST SURGERY. BASED ON THE LIMITED INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS 30-OCT-2024 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 BY A SURGEON, THE PATIENT WAS IMPLANTED WITH GALAFLEX MESH FOR HER FIRST BREAST SURGERY A FEW YEARS AGO. THE PATIENT STATED TO THE SURGEON THAT THE GALAFLEX ¿HURT¿ HER.