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

Catalog Number 3503420

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 05/21/2019

Event Type  Injury  

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: malposition.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast augmentation with mentor smooth round high profile 420cc saline breast implants which the right side deflated and the left side malpositioned after implantation.Patient had a mammogram (b)(6) 2019 that captured the rupture.Doctor performed a physical exam on (b)(6) 2019 and confirmed a right side rupture.Patient did not report any complications nor other issues or problems.As a result patient underwent bilateral removal and replacement as follow: right replaced with catalog number: shpx650, serial number: (b)(4), and left replaced with catalog number: shpx650, serial number: (b)(4) on (b)(6) 2019.This report is for the left side.

• Brand Name: MENTOR SMOOTH ROUND HIGH PROFILE
• Type of Device: 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-868
• MDR Report Key: 8896308
• MDR Text Key: 154392859
• Report Number: 1645337-2019-17178
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 00081317001669
• UDI-Public: 00081317001669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2014
• Device Catalogue Number: 3503420
• Device Lot Number: 5971145
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR