GALAFLEX
Received Dec 24, 2025 · Event occurred Dec 5, 2025
Report 1213643-2025-01270 · MDR key 23887717
Device
Generic name
Breast - Absorbable Mesh
Manufacturer
Tepha, Inc. - 3005670760Model number
NACatalog number
UNKAA128
Lot number
NI
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AS REPORTED, THE GALAFLEX MESH WAS IMPLANTED BEYOND ITS LABELED EXPIRATION DATE. THERE WAS NO ADVERSE OUTCOME ASSOCIATED WITH THE PATIENT REPORTED. THE EVENT IS CONFIRMED AS A USE RELATED ERROR, WITH NO MALFUNCTION OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE. A LOT NUMBER WAS NOT PROVIDED, AS SUCH A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. NOTE, THE EVENT DATE ((B)(6) 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.
Description of Event or Problem
AS REPORTED, AN EXPIRED GALAFLEX WAS IMPLANTED IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE; THE MESH REMAINS IMPLANTED.