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

Model Number	3544751
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.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.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: na.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast reconstruction revision with mentor memorygel,475cc silicone breast implants which the report indicates itching for the past 2 years, pain underneath her breasts, bad allergies, she has lost balance, eyes see double, swallowing is bad, colon disease, dry eye surgery twice, arthritis, disease all over her body, loose breast skin.No diagnosis as of this report.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the right side.
Additional Manufacturer Narrative
Additional information received on (b)(6) 2022, indicated that the patient reported that sonogram on wed (b)(6) 2022 showed ¿ left-sided leaking, one big lump on side, multiple system atrophy, silicone has migrated to other places, aches, and pain in breast.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on april 20, 2022 indicated that the patient underwent bilateral removal on (b)(6) 2022.Manufacturer¿s reference number: (b)(6).
Additional Manufacturer Narrative
Additional information received on june 7, 2022 indicated that patient cancelled the removal surgery.Manufacturer¿s reference number: (b)(4).

• 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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-8687
• MDR Report Key: 9305678
• Report Number: 1645337-2019-23488
• Device Sequence Number: 1864779
• Product Code: FTR
• UDI-Device Identifier: 00081317003892
• UDI-Public: 00081317003892
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/17/2019

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: 06/07/2021
• Device Model Number: 3544751
• Device Catalogue Number: 3544751
• Device Lot Number: 7337764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 01/07/2022; 04/20/2022; 06/07/2022
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 01/25/2022; 05/12/2022; 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2016
• 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; Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White