MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX 3DR; BREAST - ABSORBABLE MESH

Model Number	100043-05
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: GALAFLEX 3DR
• Common Device Name: BREAST - ABSORBABLE MESH
• Manufacturer (Section D): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer (Section G): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 25160277
• Report Number: 1213643-2026-00625
• Device Sequence Number: 18308221
• Product Code: OOD
• UDI-Device Identifier: 00810054980049
• UDI-Public: (01)00810054980049(17)290915(10)LXLN0025
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100043-05
• Device Catalogue Number: FR3D05
• Device Lot Number: LXLN0025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown