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

Catalog Number	3501490
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor asr submission reference number (b)(4).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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: capsular contracture (grade unknown).(b)(4).
Event or Problem Description
This report contains supplemental information for mentor asr submission reference number (b)(4).It was reported that a (b)(6)-year-old female patient underwent primary breast augmentation with two 575cc mentor smooth round spectrum saline breast implants and suffered bilateral capsular contracture (grade unknown) postoperatively.The patient noted that there was some visible ¿folding and bubbling¿ of her chest.As a result, the patient had the devices explanted on (b)(6) 2017.This report is for the patient¿s left-sided device.On 10/29/2019, mentor became aware that asr submission reference numbers (b)(4) were duplicated.Any additional event information, if received, will be submitted under this manufacturer¿s report number.The patient consequences have been updated based on the breadth of information available.
Additional Manufacturer Narrative
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.Manufacturer's reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9313003
• Report Number: 1645337-2019-23651
• Device Sequence Number: 19460226
• Product Code: FWM
• UDI-Device Identifier: 00081317002048
• UDI-Public: 00081317002048
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 03/06/2019
• Device Catalogue Number: 3501490
• Device Lot Number: 6912256
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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: 37 YR