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

Model Number	100042-06
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient did not heal and presented with exposed implant on the right breast post breast augmentation with implant of galaflex 3d mesh.Based on the information provided, no conclusions can be made as to the degree to which the device used in the procedure may have caused or contributed to the postoperative complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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 underwent bilateral breast augmentation with implant of galaflex 3d mesh on (b)(6) 2025.At the 4 week follow up appointment the patient presented with exposed implant on the right breast post implant.It was reported that it did not heal, and no issue was found on the left breast post implant.Surgeon planned to remove the implant on (b)(6) 2025 and to replace with new implant once the healed.No further information has been provided on whether the implant was removed.

• Brand Name: GALAFLEX 3D
• 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: 21644280
• Report Number: 1213643-2025-00207
• Device Sequence Number: 7625150
• Product Code: OOD
• UDI-Device Identifier: 00810054980315
• UDI-Public: (01)00810054980315
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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: 100042-06
• Device Catalogue Number: SH3D06
• 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: 02/24/2025
• Initial Report FDA Received Date: 03/19/2025
• 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 Sex: Female