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

Catalog Number	3503230
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 49-year-old caucasian female patient underwent a breast augmentation primary with saline mentor smooth round high profile 230cc breast implants and experienced deflation on the right side post-operatively, which was confirmed during a physical exam.As a result, the patient is scheduled for removal on (b)(6) 2023.
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.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.Date of explantation: (b)(6) 2023 reason for device explant and/or reoperation: deflation manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On sep 28, 2023, additional information was received indicating the impacted product was damaged during shipping, and was scrapped as a result by the carrier.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.Manufacturer¿s reference number: (b)(4).

• 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 17597840
• Report Number: 1645337-2023-09836
• Device Sequence Number: 20725452
• Product Code: FWM
• UDI-Device Identifier: 00081317001591
• UDI-Public: 00081317001591
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 3503230
• Device Lot Number: 6610411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2012
• 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
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White