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

Model Number	100035-09
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient experienced right breast bottoming out about 5 months post implant of galaflex thereby underwent repair with mesh explant.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.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june 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, patient underwent a mastopexy procedure with implant exchange and implant of galaflex mesh on (b)(6) 2023.It was reported that patient experienced right breast bottoming out thereby underwent a revision procedure on (b)(6) 2024 during which surgeon noticed that right breast lower pole was slightly tight and the galaflex mesh appeared to have some type of "deformity." it was reported that the mesh was removed and new galaflex mesh was implanted.

• 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: 19002938
• Report Number: 1213643-2024-00111
• Device Sequence Number: 12114025
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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: 07/31/2025
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: LXHT0003
• 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: 03/18/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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: 50 YR
• Patient Sex: Female