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

Model Number	100043-02
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Ptosis (2620); Breast Discomfort/Pain (4504)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient with the history of bilateral breast augmentation had capsular contracture of right breast which was attempted to be fixed by exchanging implants, mastopexy and it was not successful.It was reported that the right implant was bottoming out and it was decided to implant galaflex 3dr to add an extra layer bilaterally for evenness.The procedure was performed in (b)(6) 2024.It was reported that ¿both have rolled and causing pain¿.In (b)(6) 2024, patient was referred to another surgeon who confirmed that ¿the mesh had failed, implant is bottoming out and mesh is rolled and felt through my skin.¿ as reported, patient had extreme discomfort, constant pain and scheduled a removal surgery on (b)(6) 2025.
Additional Manufacturer Narrative
As reported that 6 months post implant of galaflex 3dr, patient had pain, discomfort and the mesh is bottoming out, rolled and felt through skin.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.The adverse reactions section of the instructions-for-use supplied with the device list pain as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of implant ((b)(6) 2024) and date of event (15-oct-2024) considered to be a best estimate.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 that 6 months post implant of galaflex 3dr, patient had pain, discomfort and the mesh is bottoming out, rolled and felt through skin.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.The adverse reactions section of the instructions-for-use supplied with the device list pain as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of implant ((b)(6)2024) and date of event (15-oct-2024) considered to be a best estimate.Addendum: h11: this supplemental mdr is submitted to correct the udi.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 with the history of bilateral breast augmentation had capsular contracture of right breast which was attempted to be fixed by exchanging implants, mastopexy and it was not successful.It was reported that the right implant was bottoming out and it was decided to implant galaflex 3dr to add an extra layer bilaterally for evenness.The procedure was performed in (b)(6)2024.It was reported that ¿both have rolled and causing pain¿.In (b)(6) 2024, patient was referred to another surgeon who confirmed that ¿the mesh had failed, implant is bottoming out and mesh is rolled and felt through my skin.¿ as reported, patient had extreme discomfort, constant pain and scheduled a removal surgery on (b)(6)2025.
Additional Manufacturer Narrative
As reported that 6 months post implant of galaflex 3dr, patient had pain, discomfort and the mesh is bottoming out, rolled and felt through skin.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.The adverse reactions section of the instructions-for-use supplied with the device list pain as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of implant ((b)(6)2024) and date of event (15-oct-2024) considered to be a best estimate.Addendum 1: h11: this supplemental mdr is submitted to correct the udi.Addendum 2: this supplemental mdr is submitted to update the additional information received.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 with the history of bilateral breast augmentation had capsular contracture of right breast which was attempted to be fixed by exchanging implants, mastopexy and it was not successful.It was reported that the right implant was bottoming out and it was decided to implant galaflex 3dr to add an extra layer bilaterally for evenness.The procedure was performed in (b)(6)2024.It was reported that ¿both have rolled and causing pain¿.In (b)(6) 2024, patient was referred to another surgeon who confirmed that ¿the mesh had failed, implant is bottoming out and mesh is rolled and felt through my skin.¿ as reported, patient had extreme discomfort, constant pain and scheduled a removal surgery on (b)(6)2025.Addendum: as reported, patient had surgery on (b)(6)2025 and the mesh wasn't even attached at all.

• 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: 21179439
• Report Number: 1213643-2025-00009
• Device Sequence Number: 10683783
• Product Code: OOD
• UDI-Device Identifier: 00810054980018
• UDI-Public: (01)00810054980018
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• 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,Followup,Followup
• Report Date (Section B): 02/05/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 01/23/2025; 02/04/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 01/30/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 38 YR
• Patient Sex: Female