MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GalaFlex 3D; Breast - Absorbable Mesh

Model Number	100042-01
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2024 - patient had history of breast augmentation, breast ptosis stage 1, double bubble deformity bilateral thereby underwent repair with the placement of two galaflex 3d scaffold (device 1 - right & device 2 - left).Per op notes, "attention to the breast with epinephrine was placed below at the prior imf incision and was carried down to the breast pocket.The implants were removed.Two galaflex 3d scaffold (device 1 - right & device 2 - left) were sutured down to the imf fascia.The implants were placed back into the pocket and the subcutaneous tissue.The superior and lateral glandular tissue was then incised, and the nipple areolar complex was mobilized upward to the mid portion of the implant." this file represents galaflex 3d (device 2 - left).
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This supplemental emdr represents the galaflex 3d (device 2 - left).An additional emdr was submitted to represent the galaflex 3d (device 1 - right).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 3D
• 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 ; +1(800)556-6756
• MDR Report Key: 50472623
• Report Number: 1213643-2026-01122
• Device Sequence Number: 9898471
• Product Code: OOD
• UDI-Device Identifier: 00810054980261
• UDI-Public: (01)00810054980261(17)270802(10)LXHW0025
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 100042-01
• Device Catalogue Number: SH3D01
• Device Lot Number: LXHW0025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2024
• 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 Sex: Female