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

Model Number	3501650
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	05/14/2019
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: right side rupture, and capsular contracture; baker grade unknown.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent primary breast augmentation with 300cc mentor smooth round moderate profile on the left side and with 325cc mentor smooth round moderate profile on the right and was presented with left side deflation observed per physical exam at the emergence room on (b)(6) 2019.On (b)(6) 2021, mentor became aware that the patient experienced bilateral breast implant deflation and capsular contracture; baker grade unknown.As a result, patient underwent bilateral explantation on (b)(6) 2019.The information also stated that the patient has a pending surgery on (b)(6) 2021.This report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
On february 26, 2021, mentor became aware that the patient underwent replacement surgery with catalog number 3502350; serial number (b)(6) on the left side and with catalog number 3502350; serial number (b)(6) on the right side on (b)(6) 2021.This supplemental report is for the patient¿s right-sided device.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
• MDR Report Key: 11372452
• Report Number: 1645337-2021-01866
• Device Sequence Number: 17435355
• Product Code: FWM
• UDI-Device Identifier: 00081317001256
• UDI-Public: 00081317001256
• 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
• Device Explanted Year: 2019
• 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): 02/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2007
• Device Model Number: 3501650
• Device Catalogue Number: 3501650
• Device Lot Number: 256848
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR