MAUDE Adverse Event Report: MENTOR TEXAS MENTOR Smooth Round Moderate Profile; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3501650
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Deformity/ Disfigurement (2360)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no manufacturing record evaluation review could be performed.D4: udi: as all of the device characteristics are unknown at this time, the udi is currently not available.Reason for device explant and/or reoperation: insufficient information.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast surgery with implantation of an undisclosed mentor saline breast implant prosthesis.Post-operatively, the patient underwent bilateral implant exchange with mentor saline implants on (b)(6), 2026, for an undisclosed reason.However, during the surgery, the left implant was observed to be deflated.The date of implantation was provided to mentor as a best estimate.Follow-ups are being conducted.If more information becomes available, mentor will submit a supplemental report accordingly.

• Brand Name: MENTOR Smooth Round Moderate 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 ; 9497882078
• MDR Report Key: 25906649
• Report Number: 1645337-2026-08258
• Device Sequence Number: 8385541
• Product Code: FWM
• UDI-Device Identifier: 00081317001256
• UDI-Public: 00081317001256
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup,Followup

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 Expiration Date: 11/09/2009
• Device Catalogue Number: 3501650
• Device Lot Number: 5605368
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: 07/24/2026; 08/14/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 07/30/2026; 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2005
• 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: 54 YR
• Patient Sex: Female