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

Model Number	100035-09
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient had issue with palpation of the lateral aspect of the mesh on the right breast, pain and tenderness in this area.Based on the information available, no conclusions can be made as to the degree to which the device may have caused or contributed to the patient¿s clinical course.Pain is a known inherent risk of surgery 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.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, patient was implanted with galaflex mesh by undergoing breast augmentation mastopexy on (b)(6)2023.It was reported that patient had a persistent issue with palpation of the lateral aspect of the mesh on the right breast and tenderness in this area.On (b)(6)2024, patient reported pain during hospital visit for appointment.Hence, the surgeon recommended a revision surgical procedure to remove the palpable galaflex and replace with galaflex lite.The procedure is scheduled for (b)(6)2025.

• 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: 21178337
• Report Number: 1213643-2024-00615
• Device Sequence Number: 10603159
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041(17)250731(10)LXHT0003
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: 07/31/2025
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: LXHT0003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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