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

Model Number	100035-05
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Reproductive System or Breast Problem (4513)
Date of Event	09/08/2014
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 complications including left breast extrusion and subsequent removal of the mesh.Medical affairs has assessed the patient¿s postoperative course as being serious and related to the study device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Extrusion is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reaction section of the ifu.This mdr is being submitted to report the ae of extrusion; an additional mdr shall be submitted to report the ae of erythema.Note: this mdr report is related to a retrospective study conducted to proactively gather real-world evidence on the use and safety of the p4hb product family, including galaflex scaffold, galaflex 3d, and galaflex 3dr.All safety events from the study are adjudicated by the bd medical monitor for an independent assessment of severity and relatedness.In an abundance of caution, events for which relatedness cannot be ruled out are processed for mdr reporting.
Event or Problem Description
Per clinical trial (b)(6): on (b)(6) 2014, patient underwent left breast revision augmentation and scar revision using a short scar incision.1 piece of galaflex was used.No concomitant procedures were done.On (b)(6) 2014, a second ae of left breast extrusion was reported.Patient had additional surgery on that day to remove the left breast implant and mesh.Resolved on (b)(6) 2014 without sequelae.On (b)(6) 2014, fat grafting was done to the left breast.Review by medical affairs identifies 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: 14012601
• Report Number: 1213643-2022-00130
• Device Sequence Number: 20135395
• Product Code: OOD
• UDI-Device Identifier: 00855920006003
• UDI-Public: (01)00855920006003
• 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: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2022

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 Model Number: 100035-05
• Device Catalogue Number: GP0103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 46 KG