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

Catalog Number 3542635

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 01/29/2019

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.Since no lot number was provided, no manufacturing record evaluation (mre) review could be performed.Reason for device explant and/or reoperation: device migration.(b)(4).

Event Description

It was reported that a (b)(6)-year-old hispanic female patient underwent a primary breast augmentation with mentor siltex round moderate profile 250 cc saline breast implants which the right side deflated, and issue with ptosis and the left side, the mri showed radial folds after implantation.Patient experienced a deflation of the right implant.As a result the patient underwent bilateral removal and replacement as follow: left replaced with catalog number 3507275mc, serial number (b)(4), and right replaced with catalog number 3507275mc, serial number (b)(4) on (b)(6) 2019.This report is for the left side.

• Brand Name: MENTOR SILTEX ROUND MODERATE 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: 8700241
• MDR Text Key: 148032220
• Report Number: 1645337-2019-13865
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 00081317001768
• UDI-Public: 00081317001768
• Combination Product (y/n): N
• PMA/PMN Number: P990075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3542635
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 45 YR