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 Code	Unspecified Infection (1930)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per clinical trial (b)(4): on 6/9/20, patient underwent bilateral revision reconstruction using an imf incision.The patient was hospitalized for the procedure on (b)(6) 2020 (discharged 6/10/20).2 pieces of galashape (galaflex 3d) were used.There were no concomitant procedures done.On (b)(6) 2020, right breast infection was reported.On (b)(6) 2020, patient had wash-out and debridement of right breast.Right breast implant and non adherent mesh was explanted.Reconstructive salvage with placement of new right implant (no mesh).Patient also received medication (iv antibiotics - not specified which in record).Resolved with sequelae on unknown date.Review by medical affairs identifies the reported infection as likely related to the device and serious.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient experienced post-op complications including right breast infection and underwent explant.Medical affairs has assessed the patient¿s postoperative course as being serious and likely related to the study device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Infection 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 instructions for use (ifu) supplied with the device.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 infection.An additional mdr was submitted to report additional ae of seroma.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.

• 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: 14057494
• Report Number: 1213643-2022-00144
• Device Sequence Number: 14699275
• Product Code: OOD
• UDI-Device Identifier: 00810054980292
• UDI-Public: (01)00810054980292
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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: 100042-04
• Device Catalogue Number: SH3D04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/08/2022
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 135 KG