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

Model Number	100027-09
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Rash (2033)
Date of Event	03/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post breast implants exchange using galaflex lite, patient had developed a full body rash and underwent medical intervention.Based on the information provided, no conclusions can be made as to the degree to which the device may have caused or contributed to the patient¿s post operative clinical course.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.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.
Event or Problem Description
As reported, patient underwent breast implant exchange with galaflex lite mesh on (b)(6) 2025.It was reported that patient did a full body wash with hibiclens prior to procedure due to a history of mrsa.On the day of the procedure 1gm of vancomycin was given before incision and intraoperative irrigation was done with phaseone and implants soaked in pvp-i.On (b)(6) 2025, patient went to urgent care with a rash starting on the elbows and progressed to the eyes, ears, legs, neck, and back of shoulders and was treated with prednisone, dexamethasone, benadryl, and zyrtec.On (b)(6), still presenting with rash.The patient saw a third allergist, received a xolair injection, and it appears to be helping.

• 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: 21881843
• Report Number: 1213643-2025-00343
• Device Sequence Number: 21018303
• Product Code: OOD
• UDI-Device Identifier: 00810054980582
• UDI-Public: (01)00810054980582(17)260531(10)LXJP0026
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113721
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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 Expiration Date: 05/31/2026
• Device Model Number: 100027-09
• Device Catalogue Number: GFLT1520
• Device Lot Number: LXJP0026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2024
• 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