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

Model Number	100043-02
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent a revision procedure on (b)(6) 2023 which included breast implant exchange using low profile breast implants and a breast lift with implant of the galaflex 3dr scaffold.As reported, patient followed up with the surgeon during routine office visit and the nurse demonstrated how to massage her breast.Patient reports the nurse massaged her left breast and the patient felt a tearing sensation.Patient reports shortly after that her left breast appeared to be lumpy and not symmetrical with her right breast.Patient reported her concerns to her surgeon and she reports he does not feel there is any need for any intervention at this time as he explained to her that the scaffold will resorb after 24 months.She also reports she has had in the past month an increase of pain in her left breast.
Additional Manufacturer Narrative
As reported, patient had lumpy appearance, pain in left breast after a massage technique during a routine follow post implant of galaflex 3dr.Review of the photos provided by the patient confirm the lumpy appearance that was alleged.Based on the information provided a definitive root cause for the patient's condition 7 months post op cannot be determined.The patient¿s surgeon does not feel there is any need for any intervention at this time as he explained to the patient that the scaffold will resorb after 24 months.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2022.Note, the date of event ((b)(6) 2023) is considered to be a best estimate based.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.H3 other text: not returned - remains implanted.

• Brand Name: GALAFLEX 3DR
• 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: 17912977
• Report Number: 1213643-2023-00366
• Device Sequence Number: 7497431
• Product Code: OOD
• UDI-Device Identifier: 00810054980018
• UDI-Public: (01)00810054980018
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2023

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: 09/28/2025
• Device Model Number: 100043-02
• Device Catalogue Number: FR3D02
• Device Lot Number: 220048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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