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

Model Number	100035-09
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Fluid Discharge (2686); Breast Discomfort/Pain (4504)
Date of Event	09/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient experienced the post-op complication of capsular contracture, breast pain, nipple discharge and underwent mesh removal.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.Pain is a known inherent risk of surgery and listed as a possible complication in the adverse reaction section of the instruction for use (ifu) supplied with the device.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.Not returned - mesh explanted.
Event or Problem Description
Per clinical trial (b)(4): patient has an extensive history of breast procedures.On (b)(6) 2016, patient underwent left breast revision augmentation; capsular contracture using a full vertical and horizontal t incision.No concomitant procedures were done.1 piece of galaflex was used.On (b)(6) 2016, bilateral capsular contracture was reported.In (b)(6) 2016, patient was in a car accident and experienced additional complications.On (b)(6) 2017, left nipple discharge and left breast pain reported as well as left breast capsular contracture.On (b)(6) 2018, patient had bilateral capsulectomies performed with removal of galaflex of the left breast and removal of seri scaffold of the right breast along with breast implant exchange.No additional p4hb was placed.The bilateral capsular contracture reported on (b)(6) 2016, is possibly related to p4hb, per pi.Left nipple discharge, left breast pain and left breast capsular contracture have unknown relatedness to p4hb, per pi.Capsular contracture resolved without sequelae on (b)(6) 2018.Left nipple discharge and left breast pain have unknown resolution dates, with sequelae.Review by medical affairs identifies as likely 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: 14757218
• Report Number: 1213643-2022-00445
• Device Sequence Number: 17809298
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2022

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: 01/31/2018
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: 150154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2015
• 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: 68 KG