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

Model Number	100043-06
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, patient underwent a breast repair procedure with galaflex implant on (b)(6) 2025.It was reported that the patient felt the mesh was positioned differently on each side.Placement on the right was felt to be positioned more below the breast, in contrast to the left, where it was along the side.The right side is reported to be sagging significantly.Per the patient "i am definitely not happy with the look, and the reason i got the mesh was so that they wouldn¿t sag¿at least not so quickly.These are only 7 months old.The mesh on the left comes more up the side, but the mesh on the right is more under the breast so the right breast is falling to the side and down.".
Additional Manufacturer Narrative
As reported, patient experienced migration of mesh and sagging of right breast, post implant of galaflex.Based on the information available, no conclusions can be made as to the degree to which the device may have caused or contributed to the patient's postoperative complication.Migration is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reactions section of the instructions for use (ifu) supplied with the device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (04-nov-2025) is considered to be the 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.
Additional Manufacturer Narrative
As reported, patient experienced migration of mesh and sagging of right breast, post implant of galaflex.Based on the information available, no conclusions can be made as to the degree to which the device may have caused or contributed to the patient's postoperative complication.Migration is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reactions section of the instructions for use (ifu) supplied with the device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (04-nov-2025) is considered to be the best estimate based on the date of awareness.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the product identifiers.` a review of manufacturing records was conducted and shows the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 283 units.Updated fields: b4, d4 (product catalog no., corporate lot no., udi no., expiry date, medical device model), g3, g6, h2, h4, h6, h10, h11 corrected fields: d1 (brand name), g4 (pma/510(k)).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.
Event or Problem Description
As reported, patient underwent a breast repair procedure with galaflex implant on (b)(6) 2025.It was reported that the patient felt the mesh was positioned differently on each side.Placement on the right was felt to be positioned more below the breast, in contrast to the left, where it was along the side.The right side is reported to be sagging significantly.Per the patient "i am definitely not happy with the look, and the reason i got the mesh was so that they wouldn¿t sag¿at least not so quickly.These are only 7 months old.The mesh on the left comes more up the side, but the mesh on the right is more under the breast so the right breast is falling to the side and down.".

• 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: 23618677
• Report Number: 1213643-2025-01116
• Device Sequence Number: 21354831
• Product Code: OOD
• UDI-Device Identifier: 00810054980056
• UDI-Public: (01)00810054980056(17)270822(10)LXHW0024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 100043-06
• Device Catalogue Number: FR3D06
• Device Lot Number: LXHW0024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female