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	Unspecified Infection (1930)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient developed left breast pus infection post implant of galaflex lite and underwent excision of wound tissue.Based on the information provided, 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.
Event or Problem Description
As reported, the patient underwent a bilateral subfascial breast augmentation with implant of a galaflex lite mesh that was cut in half and used bilaterally on (b)(6) 2024.It was reported that the patient developed a pus infection at the incision site on the left breast starting on (b)(6) 2024.On (b)(6) 2024 patient underwent re-excision of open area (wound tissue) and closure and started on keflex (antibiotic) and the infection was cleared.

• 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: 20424295
• Report Number: 1213643-2024-00491
• Device Sequence Number: 7627183
• 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: 36 YR
• Patient Sex: Female
• Patient Weight: 68 KG