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

Model Number	100042-04
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per clinical trial cp-1060: on (b)(6) 2019, patient underwent bilateral augmentation mastopexy using a full vertical and horizontal t incision.2 pieces of galashape (galaflex 3d) were used.No concomitant procedures were done.On (b)(6) 2019, drainage and wound dehiscence; inverted t incision on the left breast, was reported.Patient was treated with medications (cipro, silvadene cream).Also, on (b)(6) 2020, patient had debridement and closure of left wound with partial galashape mesh excision.Resolved without sequelae on (b)(6) 2020.Review by medical affairs identifies the reported drainage and wound dehiscence is likely related to the device and serious.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, the patient experienced post-op complications including wound dehiscence, drainage and underwent partial mesh explant.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.Wound dehiscence is known inherent risk of the surgery/use of the device and included as possible complication in the adverse reaction section of the instructions for use (ifu) supplied with the device.Device not returned - partially explanted.

• Brand Name: GALAFLEX 3D
• 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: 14478440
• Report Number: 1213643-2022-00290
• Device Sequence Number: 17345575
• Product Code: OOD
• UDI-Device Identifier: 00855920006171
• UDI-Public: (01)00855920006171
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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: 06/13/2021
• Device Model Number: 100042-04
• Device Catalogue Number: SH3D04
• Device Lot Number: 190279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• 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: 54 KG