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

Model Number	100035-09
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Swelling/ Edema (4577)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.As reported the patient developed with extrusion, erythema/redness, swelling post implant of galaflex mesh and underwent subsequent surgical intervention for explant.Medical affairs has assessed the aes as being likely related to the device and serious.Review of the device history records confirms the device was manufactured to specification.Extrusion is a known inherent risk of surgery/use of the device and is included as a possible complication in the adverse reaction section of the instructions-for-use (ifu).This mdr reports the ae of left breast extrusion, erythema/redness, swelling (device #1).An additional mdr was submitted to report the ae of erythema/redness (device #2).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 underwent primary bilateral pre-pec reconstruction procedure.The procedure was for oncological reason and patient was hospitalized for procedure on (b)(6) 2020 (with discharge on (b)(6) 2020).A full vertical and horizontal t incision was used with a concomitant procedure of adipodermal flap placement.2 pieces of galaflex were used.On (b)(6) 2020, left breast extrusion was reported.Patient treated with medication (levofloxacin, doxycycline, cipro, clindamycin).On (b)(6) 2020- erythema/redness of left breast was reported.There was significant partial and full thickness injuries involving the nac, worse on the left than on the right.There was redness and swelling of the left breast with drainage.The patient treated with excisional debridement and complex wound closure right breast.On (b)(6) 2020, the patient underwent left breast revision reconstruction; left extruding breast implant and mesh was removed and replaced with a new smaller breast implant and new mesh.1 new piece of galaflex (left breast only) was used in this procedure.Additionally, complex wound closure, redness/swelling on this patient for the right breast.Review of medical affairs identified that the extrusion and erythema/redness is likely related to the device and serious.Both resolved without sequelae.This file represents the device #1 (left breast).

• Brand Name: GALAFLEX
• 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: 15713680
• Report Number: 1213643-2022-00695
• Device Sequence Number: 20483392
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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: 03/31/2022
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: 190528
• 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: 12/13/2019
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 68 KG