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

Model Number	100035-15
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, the patient experienced the post-op complication of capsular contraction, underwent surgical intervention.Medical affairs has assessed the patient¿s capsular contraction as being serious and likely related to the study device.Review of the device history records confirmed the device was manufactured to specification.Not returned - remains implanted.
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2017, patient underwent bilateral revision augmentation; lower pole bottoming out (lower pole stretch defect) using a short scar incision.1 piece of galaflex was used, cut in half.There were no concomitant procedures done.On (b)(6) 2017, capsular contracture of left breast was reported.On (b)(6) 2017, patient had left breast revision augmentation for capsular contracture, using p4hb.1 new piece of galaflex was used on the left breast.Resolved without sequelae on (b)(6) 2017.Review by medical affairs identifies the capsular contracture as related to the device and serious.

• Brand Name: GALAFLEX
• 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: 14799492
• Report Number: 1213643-2022-00461
• Device Sequence Number: 12026358
• Product Code: OOD
• UDI-Device Identifier: 00855920006034
• UDI-Public: (01)00855920006034
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

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: 01/31/2018
• Device Model Number: 100035-15
• Device Catalogue Number: GP0408
• Device Lot Number: 150155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2015
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 57 KG