MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3543607MC
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/12/2019
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: rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old female patient who underwent primary breast augmentation with two 360cc mentor memorygel breast implants, suffered bilateral rupture post-operatively.As a result, the patient was scheduled for bilateral implant explantation on (b)(6) 2019.This medwatch form is for the right breast prosthesis.
Additional Manufacturer Narrative
On 8/29/2019, mentor became aware that the patient only suffered left side rupture, instead of the bilateral rupture initially reported.Mentor also became aware that the patient also suffered left side capsular contracture; baker grade unknown, post-operatively.Mentor also became aware that the patient had undergone bilateral removal and replacement with two unspecified mentor gel implants.On 9/24/2019, mentor became aware that the incorrect date of implantation was erroneously indicated in the initial report.The correct date of implantation for the suspect medical device has been updated to: (b)(6) 2016.Manufacturer¿s reference number: (b)(4).This medwatch form is for the right breast prosthesis.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8912147
• Report Number: 1645337-2019-17513
• Device Sequence Number: 1658479
• Product Code: FTR
• UDI-Device Identifier: 00081317004424
• UDI-Public: 00081317004424
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2020
• Device Catalogue Number: 3543607MC
• Device Lot Number: 7007413
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/24/2019
• 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: 54 YR