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

Model Number	100042-06
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Necrosis (1971); Scar Tissue (2060)
Date of Event	11/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient experienced post-op complication of necrosis.Medical affairs has assessed the patient¿s postoperative course as being serious and likely related to the study device.Review of the device history records confirmed the device was manufactured to specification.This mdr represents the galaflex 3d (device #1).An additional mdr was submitted to represent the galaflex 3d (device #2).Not returned - remains implanted.
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2017, patient underwent bilateral augmentation mastopexy using a vertical incision.Two pieces of galaflex 3d (device #1 and device #2) were used.On (b)(6) 2017, necrosis; left areola was reported.Patient was treated with medication (nitrobid, betadine wipes).Resolved with sequelae on (b)(6) 2018.Patient is reported to have a left areolar scar.As reported the patient¿s ae was assessed by the clinician as severe and a serious adverse event.Review by medical affairs identifies the reported necrosis is likely related to the device and serious.

• Brand Name: GALAFLEX 3D
• 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: 15713375
• Report Number: 1213643-2022-00683
• Device Sequence Number: 17792338
• Product Code: OOD
• UDI-Device Identifier: 00855920006195
• UDI-Public: (01)00855920006195
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• 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): 10/17/2022

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: 04/07/2018
• Device Model Number: 100042-06
• Device Catalogue Number: SH3D06
• Device Lot Number: 170422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2017
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 73 KG