GALAFLEX 3DR
Received May 13, 2026 · Event occurred Apr 21, 2026
Report 1213643-2026-00625 · MDR key 25160277
Device
Generic name
Breast - Absorbable Mesh
Manufacturer
Tepha, Inc. - 3005670760Model number
100043-05Catalog number
FR3D05
Lot number
LXLN0025
Product problems
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS REPORTED, DURING A SURGERY, THE EDGES OF GALAFLEX 3DR FELL OFF, WITHOUT THE CUSTOMER CUTTING THEM. THERE WAS NO PATIENT HARM OR INJURY.
Additional Manufacturer Narrative
AS REPORTED, DURING A SURGERY, THE EDGES OF GALAFLEX 3DR FELL OFF, WITHOUT THE CUSTOMER CUTTING THEM. THE PHOTO PROVIDED SHOWS THE RIM OF A GALAFLEX 3DR DETACHED FROM THE MESH. BASED ON THE PHOTO IT IS MOST LIKELY THE RIM MAY HAVE TORN FROM OVER HANDLING AND STRETCHING OF THE RIM. HOWEVER, THE PHOTO DOES NOT ASSIST IN DETERMINING ROOT CAUSE. ADDITIONAL FOLLOW-UP IS ONGOING TO OBTAIN INFORMATION AND TO CONFIRM THE SAMPLE AVAILABILITY. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSIONS CAN BE MADE. 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.