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

Model Number	100027-15
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, patient underwent a bilateral implant exchange, submuscular to subfascial, bilateral superior pedicle mastopexy, re attachment of pec major muscle, bilateral breast fat graft and galaflex lite mesh placement which was cut in half and used bilaterally on (b)(6) 2024.As reported, the patient developed cellulitis on the right breast starting on (b)(6) 2024 and patient was treated with antibiotics (doxycycline and rifampin) with resolution of infection.
Additional Manufacturer Narrative
As reported, patient developed right breast cellulitis post implant of galaflex lite.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.Review of manufacturing records confirms product was manufactured to specification.Infection is clinically understood potential complications of surgery and identified in the adverse reaction section of the instructions-for-use, supplied with the device as possible complications.Regarding infection, the warnings section states, "if an infection develops, treat the infection aggressively.An unresolved infection may require the removal of the scaffold." 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.

• Brand Name: GALAFLEX LITE
• 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: 20422886
• Report Number: 1213643-2024-00490
• Device Sequence Number: 8419976
• Product Code: OOD
• UDI-Device Identifier: 00810054980575
• UDI-Public: (01)00810054980575(17)250831(10)LXHU0029
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K113721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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: 08/31/2025
• Device Model Number: 100027-15
• Device Catalogue Number: GFLT1020
• Device Lot Number: LXHU0029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 69 KG