MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PLUS PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3502425
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.Reason for device explant and/or reoperation: d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.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 augmentation revision procedure with a mentor smooth round moderate plus profile 425cc saline breast prosthesis (left device) and an unspecified mentor saline breast prosthesis (right device) when the left breast prosthesis deflated post implantation.Additionally, the patient suffered from bilateral breast hyperplasia.As a result, the patient underwent unilateral explantation and replacement of the left breast prosthesis was an unspecified mentor smooth saline breast prosthesis on (b)(6) 2025.The right breast prosthesis was not operated on and remains implanted.This medwatch report is for the patient¿s right breast prosthesis.
Additional Manufacturer Narrative
On 15-oct-2025, a manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 22-sep-2025, mentor received additional information about the event: - an updated event date was provided (15-may-2025).- the suspect medical device is a mentor smooth round moderate plus profile 425cc saline breast prosthesis, catalog #3502425, lot #2016373, serial # (b)(6), pma #p990075.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Manufacturer¿s reference number: (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 ; 9497882078
• MDR Report Key: 23057509
• Report Number: 1645337-2025-10218
• Device Sequence Number: 18478396
• Product Code: FWM
• UDI-Device Identifier: 00081317001447
• UDI-Public: (01)00081317001447(17)281205(10)2016373
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3502425
• Device Lot Number: 2016373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 10/15/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/08/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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
• Patient Age: 42 YR
• Patient Sex: Female