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

Catalog Number	3501645
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Pocket Erosion (2013); Local Reaction (2035)
Date of Event	04/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast augmentation revision surgery with implantation of a 300cc mentor smooth round moderate profile saline breast implant prosthesis.Immediate post-operative issues occurred where the patient reported experiencing significant swelling and bruising of the right breast with loss of sensation on the right side.The right implant apparently folded and capsular contracture developed with persistent and significant pain on the right side.A drain was subsequently placed, after which the condition temporally improved.The implant later eroded through the skin, requiring emergency surgical removal, and that there was concern for a serious infection.No confirmed diagnosis of infection was provided.Later, the patient indicated that the same implant was reimplanted under the breast and is continuing to causing ongoing symptoms including breast deformity, persistent hardness, and daily discomfort.The patient expressed concern regarding a potentially defective implant.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Mentor smooth round moderate profile breast implants are not intended for reuse/reimplantation, thus the user used the device in error.Follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.
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.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.Reason for device explant and/or reoperation: capsular contracture, local reaction, device extrusion 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: pc-002254732.

• 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: 50872582
• Report Number: 1645337-2026-10623
• Device Sequence Number: 18820419
• Product Code: FWM
• UDI-Device Identifier: 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: 2016
• 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 Expiration Date: 05/19/2020
• Device Catalogue Number: 3501645
• Device Lot Number: 7332222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2016
• 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 Sex: Female