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

Model Number	100027-30
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient underwent implant of galaflex lite and post implant the mesh was identified to be malpositioned and freely floating around the implant site.It was reported that the patient underwent revision surgery, during which the affected mesh was explanted, and a new galaflex lite mesh was implanted.Based on the information provided, no conclusions can be made.Migration is known inherent risk 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.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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 underwent implant of galaflex lite on (b)(6) 2026 and post implant the mesh was identified to be malpositioned and freely floating around the implant site.It was reported that the patient underwent revision surgery on (b)(6) 2026, during which the affected mesh was explanted, and a new galaflex lite mesh was implanted.Reportedly, the mesh was not incorporated at all and came out in one solid piece.

• Brand Name: GALAFLEX LITE
• Common Device Name: BREAST - 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: 25523293
• Report Number: 1213643-2026-00760
• Device Sequence Number: 10607050
• Product Code: OOD
• UDI-Device Identifier: 00810054980612
• UDI-Public: (01)00810054980612(17)271031(10)LXKY0032
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100027-30
• Device Catalogue Number: GFLT0015
• Device Lot Number: LXKY0032
• 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: 06/03/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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