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

Model Number	100043-01
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent breast augmentation surgery on (b)(6) 2022, during which a galaflex 3dr was implanted.On (b)(6) 2023 and/or (b)(6) 2024 and/or (b)(6) 2026, the galaflex mesh was surgically excised due to the reported pain and injury.Patient was injured severely and permanently.As alleged, the patient experienced surgical intervention, mental anguish and pain.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." the patient's attorney also alleges that the patient had subsequent surgical intervention to remove the mesh; however, no details have been provided.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.Should additional information be provided, a supplemental emdr will be submitted.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 ; +1(800)556-6756
• MDR Report Key: 50471322
• Report Number: 1213643-2026-01121
• Device Sequence Number: 10264563
• Product Code: OOD
• UDI-Device Identifier: 00810054980001
• UDI-Public: (01)00810054980001(17)260208(10)LXGU0002
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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 Expiration Date: 02/08/2026
• Device Model Number: 100043-01
• Device Catalogue Number: FR3D01
• Device Lot Number: LXGU0002
• 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: 08/04/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2022
• 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