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	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient developed infection in right breast after use of galaflex lite thereby underwent repair with mesh removal.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.The instructions-for-use supplied with the device lists infection as a possible complication.In regard to infection, the warnings section in ifu states, "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 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, during breast augmentation procedure on (b)(6) 2024, the patient was implanted with galaflex lite scaffold.About two months post-implant patient developed an infection on right side (left side was unaffected).It was reported that the galaflex lite was surgically removed to treat the infection on (b)(6) 2024.As reported by the or nurse, "when they opened the breast pocket up they removed ¿the galaflex in a pus ball¿.

• 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: 19557164
• Report Number: 1213643-2024-00316
• Device Sequence Number: 4734844
• Product Code: OOD
• UDI-Device Identifier: 00810054980575
• UDI-Public: (01)00810054980575
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K113721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: 01/31/2025
• Device Model Number: 100027-15
• Device Catalogue Number: GFLT1020
• Device Lot Number: LXHQ0010
• 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: 06/06/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2023
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 68 KG