MAUDE Adverse Event Report: Mentor Texas MENTOR Smooth Round Moderate Plus Profile; Prosthesis, breast, inflatable, internal, saline

Catalog Number	3502225
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per additional information received on october 06, 2026, the patient scheduled for removal surgeries on (b)(6) 2026, date of event updated to (b)(6) 2026.Reason for device explant and/or reoperation: device migration, deflation.Manufacturer¿s reference number: pc-(b)(4).

• Brand Name: MENTOR Smooth Round Moderate Plus Profile
• Common Device Name: Prosthesis, breast, inflatable, internal, saline
• Manufacturer (Section D): Mentor Texas; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): Mentor Texas; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: henry boden ; 3041 skyway circle north; irving, TX 75038 ; +1(949)788-2078
• MDR Report Key: 50951870
• Report Number: 1645337-2026-10892
• Device Sequence Number: 18525154
• Product Code: FWM
• UDI-Device Identifier: 00081317001362
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3502225
• Device Lot Number: 9982479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2024
• 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: Other; Required Intervention
• Patient Sex: Female
• Patient Race: White