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

Model Number	100035-15
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported that 1 year after surgery, patient experienced bottoming out, no support post implant of galaflex mesh.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.Per ifu, "pre-clinical implantation studies indicate that galaflex scaffold retains approximately 70% of its strength at 12 weeks.Bioresorption of the scaffold material will be essentially complete within 18-24 months." note, the date of event (b)(6) 2021 is considered to be a best estimate.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 breast augmentation with mastopexy procedure with implant of galaflex on (b)(6) 2021 and reported ¿galaflex did not work.The patient¿s tissue is still weak and must redo her procedure using more galaflex." it was reported that mesh was "bottoming out (no support) approximately 1 year after surgery." it was also reported that patient is "healthy, only takes vitamins.".

• Brand Name: GALAFLEX
• 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: 19467426
• Report Number: 1213643-2024-00287
• Device Sequence Number: 20711702
• Product Code: OOD
• UDI-Device Identifier: 00855920006034
• UDI-Public: (01)00855920006034
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: 09/30/2023
• Device Model Number: 100035-15
• Device Catalogue Number: GP0408
• Device Lot Number: 210095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2021
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 54 KG