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

Catalog Number	3501645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Cancer (1759)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast surgery with implantation of a 300cc mentor smooth round moderate profile saline breast implant prosthesis.Post-operatively, the patient reported developing cancer in the left breast and she can feel the plastic bag of the right implant.To date, the pathology/cytology report has not been provided.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.This report is for the left breast prosthesis. .
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.D4: udi: as the lot and expiration date for the device involved in the event was not provided, the full udi is currently not available.Reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time.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).

• 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 ; +1(949)788-2078
• MDR Report Key: 50376482
• Report Number: 1645337-2026-09407
• Device Sequence Number: 9974991
• Product Code: FWM
• UDI-Device Identifier: 00081317001249
• UDI-Public: 00081317001249
• 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: 2003
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3501645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female