MAUDE Adverse Event Report: TEPHA, INC. GALAFLEX 3D; GALAFLEX 3D (ALSO KNOWN AS GALASHAPE 3D),

Model Number	100042-07
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records were reviewed and the product met all specifications throughout the manufacturing process.The sterilization process met all validated parameters.This issue is listed as a possible adverse reaction within the ifu: adverse reactions possible complications include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect.In pre-clinical testing, galaflex scaffold elicited a minimal tissue reaction characteristic of foreign body response to a substance.The tissue reaction resolved as the scaffold was resorbed.
Event or Problem Description
Physician reported to manufacturer's representative that he had a patient that had surgery on (b)(6) 2019 for a breast lift with galaflex mesh.Additional procedures included abdominoplasty as well as brachioplasty.The mesh was used as an overlay over the central breast mound and around the areola.Everything was progressing completely normally until (b)(6) 2019 when the patient developed the abscess over the right breast requiring drainage after failure to respond to antibiotics.She appeared to have resolved with incision and drainage as well as doxycycline and the issue was in the process of resolution.However, on a recent follow-up examination, the patient was presenting with device extrusion so the surgeon decided to remove portions of the device.

• Brand Name: GALAFLEX 3D
• Common Device Name: GALAFLEX 3D (ALSO KNOWN AS GALASHAPE 3D),
• Manufacturer (Section D): TEPHA, INC.; 99 hayden ave; suite 360; lexington MA 02421
• MDR Report Key: 11577338
• Report Number: 3005670760-2021-00004
• Device Sequence Number: 3599555
• Product Code: OOD
• UDI-Device Identifier: 00855920006201
• UDI-Public: 01008559200062011721101210190525
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 10/12/2021
• Device Model Number: 100042-07
• Device Catalogue Number: SH3D07
• Device Lot Number: 190525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR