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

Model Number	100043-02
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported patient had serous yellow fluid and underwent explant post implant of galaflex 3dr in the breast.Based on the information provided, no conclusions can be made as to what if any extent the mesh caused or contribute to the patients post operative course.Seroma is known inherent risk of the surgery/use and is listed in the adverse reactions section of the instructions-for-use supplied with the device, as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 384 units.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, the patient had a bilateral breast implant exchange with capsulectomy and placement of cohesive implants on (b)(6) 2025.Patient came in for follow up on (b)(6) 2025 for bilateral swelling.No redness, warmth, or bilateral swelling found.It ws reported that on (b)(6) 2025 the patient went into or fpr what was thought to be (r) breast hematoma evacuation, but once opened no blood was found, only a significant amount of serous yellow fluid; found on both sides, but more so on the (r) than the (l).The surgeon removed both galaflex meshes.

• Brand Name: GALAFLEX 3DR
• Common Device Name: 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: 21937464
• Report Number: 1213643-2025-00352
• Device Sequence Number: 7985205
• Product Code: OOD
• UDI-Device Identifier: 00810054980018
• UDI-Public: (01)00810054980018(17)270802(10)LXHW0020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2025

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: 100043-02
• Device Catalogue Number: FR3D02
• Device Lot Number: LXHW0020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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