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

Model Number	100043-02
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Seroma (2069)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient was diagnosed with infection, seroma, wound dehiscence, implant extrusion and explant post implant of galaflex 3dr.Photo provided shows the explanted scaffold.Based on the information provided, no conclusions can be made as to what if any extent the mesh caused or contribute to the patients post operative course.Infection, seroma, wound dehiscence and extrusion are known inherent risk of the surgery/use and are listed in the adverse reactions section of the instructions-for-use supplied with the device, as possible complications.In regard 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." 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 may 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.H3 other text : not returned.
Event or Problem Description
As reported, during revision bilateral breast augmentation procedure on (b)(6) 2023 patient was implanted with galaflex 3dr on both sides.It was reported that about 3 weeks post implants patient was presented with seroma, infection, implant extrusion and wound dehiscence thereby underwent revision of breast augmentation on (b)(6) 2023 with breast implants removal and galaflex placement.Surgeon reported that galaflex 3dr increased the seroma rate after surgery and the seroma leaked into the wound which likely got infected causing wound dehiscence.

• Brand Name: GALAFLEX 3DR
• 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: 18501649
• Report Number: 1213643-2023-00529
• Device Sequence Number: 7864435
• Product Code: OOD
• UDI-Device Identifier: 00810054980018
• UDI-Public: (01)00810054980018
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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: 100043-02
• Device Catalogue Number: FR3D02
• Device Lot Number: LXHQ0006
• 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: 12/20/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 62 KG