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

Model Number	100042-03
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient experienced wound dehiscence and treated with wound care post implant of galaflex 3d.Based on the information provided, no conclusions can be made.Wound dehiscence is a known inherent risk of surgery/use of the device and is included as a possible complication in the adverse reaction section of the instructions-for-use (ifu).Review of manufacturing records confirms product was manufactured to specification.This mdr reports the ae of right breast (device #1).An additional mdr was submitted to report the ae of left breast (device #2).Note, the date of event (24-apr2024) is considered to be a best estimate based on the date of awareness.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 - remains implanted.
Event or Problem Description
As reported, the patient underwent a bilateral mastopexy with breast implants and a galaflex 3d.It was reported that the patient experienced bilateral incisional wound dehiscence post-operatively.The patient was treated with wound care and the right breast was healed; however, on the left breast side, the wound remains open and did not appear to be incorporating.As reported, surgeon is considering a revision procedure to possibly remove the mesh bilaterally.

• Brand Name: GALAFLEX 3D
• 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: 19277642
• Report Number: 1213643-2024-00243
• Device Sequence Number: 7592288
• Product Code: OOD
• UDI-Device Identifier: 00810054980285
• UDI-Public: (01)00810054980285
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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 Model Number: 100042-03
• Device Catalogue Number: SH3D03
• Device Lot Number: LXHR0032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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: 46 YR
• Patient Sex: Female