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

Model Number	100027-33
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Rash (2033)
Date of Event	02/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported on 01-feb-2026, the patient underwent implant of galaflex lite.Post two (2) weeks of implantation the patient had experienced full body rashes.Reportedly, the patient had no known allergies before.The patient was treated with topical ointments and steroids with no resolution of the rash.The patient underwent reactivity testing with the provided galaflex sample.The reactivity test was negative, and the patient had no sensitivities to any of the surgical products tested.As per the allergist, they will attempt testing of the silicone implant material as this was the last material to be tested.
Additional Manufacturer Narrative
As reported, a patient was implanted with galaflex lite, post two (2) of implantation patient had a full body rash.Reactivity testing has been performed and as reported the results were negative for an allergic response to the galaflex lite sample.It is unknown at this time, what is causing the patient's postoperative rashes.However, based on testing performed the postoperative conditions experienced by the patient do not appear to be caused by the galaflex lite used to treat the patient.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.The adverse reaction section in ifu states, "in pre-clinical testing, the galaflex lite scaffold elicited a minimal tissue reaction characteristic of foreign body response to a substance.The tissue reaction resolved as the scaffold was absorbed." 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.

• 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: 24948774
• Report Number: 1213643-2026-00539
• Device Sequence Number: 16031132
• Product Code: OOD
• UDI-Device Identifier: 00810054980797
• UDI-Public: (01)00810054980797(17)271031(10)LXKY0029
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 06/30/2026

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: 100027-33
• Device Catalogue Number: GFLT0022
• Device Lot Number: LXKY0029
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2025
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Female