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

Model Number	100043-05
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the galaflex 3dr was used for a breast lift procedure and it is reported that the repair did not hold.Based on the information provided, no conclusions can be made.To date, this is the only reported complaint for this manufacturing lot.Note, the date of event is considered to be a best estimate as (b)(6) 2022 based on the information provided.Not returned - remains implanted.
Event or Problem Description
As reported, the patient underwent bilat breast implant exchange and breast lift on (b)(6) 2022.As reported, the patient presented shortly after the procedure with both breast dropping significantly and not lifted as expected.As reported, the surgeon would like to repair the patient's breasts, but he cannot at this time since the galaflex has not fully resorbed.

• 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: 15729608
• Report Number: 1213643-2022-00703
• Device Sequence Number: 16876693
• Product Code: OOD
• UDI-Device Identifier: 00810054980049
• UDI-Public: (01)00810054980049
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

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: 03/07/2025
• Device Model Number: 100043-05
• Device Catalogue Number: FR3D05
• Device Lot Number: 210345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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