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

Catalog Number	3544700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/01/2016
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 is in progress.Once completed, a supplemental report will be submitted.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 primary breast reconstruction with two 700cc mentor memorygel breast implant and suffered several unexplained systemic symptoms, including burning, pain, heaviness, chest pressure across entire breast and back but primarily on the left-side, fatigue and joint pain.No device issue such as rupture was reported.The root cause of the patient¿s symptoms is unclear.This was the patient¿s primary reconstruction procedure after a breast cancer diagnosis in (b)(6) 2016.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the right prosthesis.
Additional Manufacturer Narrative
On 12/2/2019, a manufacturing record evaluation (mre) was completed.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.The device manufacture date was updated to 1/18/2016 per mre.The relevant field has bee updated.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
• MDR Report Key: 9388398
• Report Number: 1645337-2019-24613
• Device Sequence Number: 3104479
• Product Code: FTR
• UDI-Device Identifier: 00081317001157
• UDI-Public: 00081317001157
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 01/21/2021
• Device Catalogue Number: 3544700
• Device Lot Number: 7282490
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/28/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: Other
• Patient Age: 46 YR