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

Model Number	3503230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	01/01/2007
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 21-year old caucasian female patient underwent primary breast augmentation with a (left) 230cc mentor smooth round high profile saline (july 12, 2007) and breast augmentation revision with a (right) unspecified mentor saline implant ((b)(6) 2012).Post-operatively, the patient suffered bilateral breast pain, and rippling on the right breast.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch form 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.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: n/a.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).
Additional Manufacturer Narrative
On (b)(6) 2022, mentor became aware that the patient had already previously reported the initially reported device (catalog: 3503230 lot: 5719561 sn: (b)(6) for left breast implant deflation on (b)(6) 2012 under complaint file 214743.The patient's current complications are on the replacement device: 210cc mentor smooth round high profile saline (catalog: 3503210 lot: 6589160 sn: (b)(6), which was implanted on (b)(6) 2012.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.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On november 21, 2023, mentor received additional information indicating that the patient has been scheduled for bilateral breast implant removal and replacement surgery on (b)(6) 2023.The replacement devices will be mentor silicone implants.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.Reason for device explant and/or reoperation: breast pain.

• Brand Name: MENTOR SMOOTH ROUND HIGH 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14758659
• Report Number: 1645337-2022-07248
• Device Sequence Number: 1294334
• Product Code: FWM
• UDI-Device Identifier: 00081317001584
• UDI-Public: 00081317001584
• 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: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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 Expiration Date: 05/31/2016
• Device Model Number: 3503230
• Device Catalogue Number: 3503210
• Device Lot Number: 6589160
• 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: 05/27/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 11/21/2023
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/26/2022; 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2012
• 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; Other
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White