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

Model Number	3503190
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	08/21/2020
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.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: pain and pressure in the patient's breasts.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female patient who underwent a primary breast augmentation with a 210cc mentor smooth round high profile prosthesis (left) and a 190cc mentor smooth round high profile prosthesis (right) experienced bilateral local reaction postoperatively.The patient experienced sharp breast pain and pressure in her breasts.The patient stated that her right breast appeared larger than the left side.Due to the symptoms, the patient had a consultation with a healthcare professional.However, no diagnosis was confirmed.The patient underwent bilateral removal without replacement on (b)(6) 2020.The surgeon¿s office stated the patient underwent the revision surgery by her own choice without confirmed diagnosis.The patient retained the devices after the revision surgery.This report is for the right-sided prosthesis.
Additional Manufacturer Narrative
On (b)(6) 2021, mentor received additional information regarding the patient's symptoms.The patient experienced the symptoms in the u.S.On (b)(6) 2021, it was found that patient's information and symptoms were omitted on the initial report.On (b)(6) 2021, mentor received additional information regarding the patient¿s symptoms.The patient appeared to have experienced bilateral local reaction, and the side of deflation was the right side.The relevant fields have been updated.Updated reason for device explant and/or reoperation: pain and pressure in the patient's breasts, deflation.Manufacturer's reference number: (b)(4), the patient lives in canada.However, the patient went to florida for the primary breast augmentation, experienced the symptoms, and decided to undergo bilateral removal without replacement.The patient initially stated that she experienced deflation and hematoma (unknown side).In addition, the patient experienced difficulty breathing/shortness of breath, anxiety, and excess amount of sweat.However, no diagnosis was confirmed when the patient had a consultation with her surgeon.The root cause of the patient¿s symptoms is unclear.Blood work done in canada did not indicate any issues.The patient stated that her symptoms were all improved after the removal surgery.

• 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
• MDR Report Key: 11269968
• Report Number: 1645337-2021-00989
• Device Sequence Number: 5036686
• Product Code: FWM
• UDI-Device Identifier: 00081317001577
• UDI-Public: 00081317001577
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: 08/05/2024
• Device Model Number: 3503190
• Device Catalogue Number: 3503190
• Device Lot Number: 9490148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR