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

Model Number	100035-15
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, galaflex did not completely incorporate three months post-implant of the mesh.Based on the information provided, no conclusions can be made.The instructions for use supplied with the device states that "bioresorption of the scaffold material will be essentially complete within 18-24 months." review of manufacturing records confirms product was manufactured to specification.Note, the date of event is considered to be a best estimate as on (b)(6) 2023 based on the information available.
Event or Problem Description
As reported, patient who had a history of heavy smoking was diagnosed with large hematoma on right side of the breast and underwent right side unilateral breast repair surgery (implant removal, capsulectomy, and implant replacement) with the implant of galaflex on (b)(6) 2022.It was reported that over 3 months later, patient could feel the galaflex mesh and it did not completely incorporate.

• Brand Name: GALAFLEX
• 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: 16598986
• Report Number: 1213643-2023-00112
• Device Sequence Number: 1688091
• Product Code: OOD
• UDI-Device Identifier: 00855920006034
• UDI-Public: (01)00855920006034
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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: 09/30/2023
• Device Model Number: 100035-15
• Device Catalogue Number: GP0408
• Device Lot Number: 210095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• 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: 46 YR
• Patient Sex: Female