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

Model Number	100042-05
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/22/2016
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 extrusion, infection and subsequent surgery for explant.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 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." 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.
Event or Problem Description
Per clinical trial cp-1060: on (b)(6) 2016, patient underwent a revision left side central mound breast mastopexy/reduction with a full vertical and horizontal t incision.Concomitant procedures included right revision and fat grafting.One piece of galashape (galaflex 3d) was used.On (b)(6) 2016, mesh extrusion was reported.Incision had drainage and odor.Patient was instructed how to do wet to dry dressing changes twice daily.Incision was red and tender.With dressing changes, incision began to fill and granulate slowly.On (b)(6) 2017, patient presented with infection in left breast.Dressing changes continued.Exposed mesh was debrided on both (b)(6) 2017 and (b)(6) 2017.Aquaphor ointment applied.Excision and primary closure with medications (bactrim, bactroban and cipro) performed on (b)(6) 2017.Problem reported to have resolved on (b)(6) 2017.Review by medical affairs identifies this as 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: 13724011
• Report Number: 1213643-2022-00053
• Device Sequence Number: 14948783
• Product Code: OOD
• UDI-Device Identifier: 00810054980308
• UDI-Public: (01)00810054980308
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: 100042-05
• Device Catalogue Number: SH3D05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 03/10/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 82 KG