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

Model Number	100043-04
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Breast Discomfort/Pain (4504); Unspecified Reproductive System or Breast Problem (4513)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient experienced pain and discomfort post implant of galaflex 3dr mesh.Based on the information available and without having the sample to evaluate, no conclusions can be made.Pain is a known inherent risk of surgery/use of the device and is included as a possible complication in the adverse reaction section of the instructions-for-use (ifu).Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 321 units released for distribution in apr, 2021.Not returned - remains implanted.
Event or Problem Description
As reported, the patient underwent a bilateral breast mastopexy with breast implants augmentation and implant of a galaflex 3dr scaffold on (b)(6) 2021.As reported, the patient started experiencing significant dropping of both breasts with pain and discomfort about 3 months later.It was reported that prior to the procedure recommended to have the breast implants as well as the galaflex 3dr scaffold to support the breast lift.It was also reported that the results are not what the surgeon discussed during her consultation.As reported, the patient frustrated and consulted with another surgeon on (b)(6) 2022.The surgeon now recommending she have the implants removed and another breast lift procedure.As reported, the patient continues to have pain and discomfort in both her breasts since the procedure in (b)(6) 2021.

• 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: 15729519
• Report Number: 1213643-2022-00705
• Device Sequence Number: 11481370
• Product Code: OOD
• UDI-Device Identifier: 00810054980032
• UDI-Public: (01)00810054980032
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

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: 11/06/2024
• Device Model Number: 100043-04
• Device Catalogue Number: FR3D04
• Device Lot Number: 210106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• 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: 34 YR
• Patient Sex: Female