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 Code	Unspecified Infection (1930)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient developed right breast infection post implant of galaflex thereby underwent excision of mesh.Based on the information available, no conclusions can be made as to the degree to which the device may have caused or contributed to the patient¿s clinical course.Infection is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use, supplied with the device as a possible complication.The warnings section states, "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in april 2023.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, on (b)(6) 2024 patient underwent bilateral breast implant exchange neosubpectoral pocket procedure with implant of galaflex scaffold to the lower poles.It was reported, the mesh was cut in half, used bilaterally and 5 days post implant of the mesh patient diagnosed with infection only in the right breast.As reported on (b)(6) 2024 the mesh was removed, and patient underwent second surgery for exploration, washout and debridement on (b)(6) 2024.Patient was on oral and iv antibiotics by infectious disease physicians.Antibiotics stopped on (b)(6) 2024 and picc line removed (b)(6) 2024.It was also reported that patient is scheduled for a right breast augmentation, imf incision, subpectoral pocket and right breast lower pole support with galaflex on (b)(6) 2024.

• 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: 20630441
• Report Number: 1213643-2024-00529
• Device Sequence Number: 20697592
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041(17)250630(10)LXHQ0008
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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: 06/30/2025
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: LXHQ0008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2023
• 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: 39 YR
• Patient Sex: Female