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

Model Number	100042-01
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2019, patient underwent bilateral revision augmentation; implant malposition using a horizontal incision in imf.2 pieces of galashape (galaflex 3d) (device1, device2) were used.On (b)(6) 2019, a sae of breast infection was reported.Patient had been hospitalized the previous week (no date given).Patient was seen by infectious disease and doctor put on broad spectrum antibiotic medication (unknown meds).Resolved without sequelae on (b)(6) 2019.On that (b)(6) 2019 follow up visit, it was noted that the patient felt that the mesh hadn't held things up in the right breast and the left breast had contracted.Revision right breast capsulorrhapy utilizing strattice mesh on (b)(6) 2019.Completed without complications.Review by medical affairs identifies the infection and contracture as likely related to the device and serious.This file represents the device #1.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient experienced post-op complications including left breast infection and contracture.Medical affairs has assessed the patient¿s postoperative course as being serious and likely related to the study device.Infection is a known inherent risk of the surgery and listed as a possible complications in the adverse reaction section of the instructions for use (ifu).In regards to infection, the warnings section of the ifu states, "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." this mdr reports the ae of left breast infection and contracture (device #1).An additional mdr was submitted to report the ae of right breast infection and malposition (device #2).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.Device not returned.

• 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: 15713684
• Report Number: 1213643-2022-00693
• Device Sequence Number: 17806495
• Product Code: OOD
• UDI-Device Identifier: 00855920006140
• UDI-Public: (01)00855920006140
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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: 09/09/2020
• Device Model Number: 100042-01
• Device Catalogue Number: SH3D01
• Device Lot Number: 180283
• 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: 11/28/2018
• 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: Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 73 KG