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

Model Number	100042-03
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/18/2020
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 right breast infection and explant procedure.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.Infection is a known inherent risk of the surgery and included as a possible complication in the adverse reactions 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 is being submitted to report for galaflex 3d (device #2); an additional mdr shall be submitted to report the galaflex (device #1).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 cp-1060: on (b)(6) 2020, patient underwent right breast revision reconstruction using an imf incision.Patient was hospitalized and was discharged the following day (b)(6) 2020.One piece of galaflex and one piece of galashape (galaflex 3d) were both used.No concomitant procedures were done.On (b)(6) 2020, right breast infection was reported.Patient was hospitalized on (b)(6) 2020, where washout and debridement with removal of breast implant was performed on that date.Per notes, there was some evidence of nonadherent p4hb matrix just inferior to the nipple areolar complex that was sharply debrided.There was opacity of adequate soft tissue just below the inverted nipple with a definitive track to the breast pocket.A small amount of nonadherent p4hb was removed from the patient using curettes.Also treated with medication (cipro and clindamycin).Resolved with sequelae on unknown date.Review by medical affairs identifies the reported adverse event is related to the device and serious.

• 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: 13800594
• Report Number: 1213643-2022-00085
• Device Sequence Number: 3837309
• Product Code: OOD
• UDI-Device Identifier: 00855920006164
• UDI-Public: (01)00855920006164
• 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): 03/08/2022

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: 100042-03
• Device Catalogue Number: SH3D03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/17/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 49 KG