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

Catalog Number	3544457MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); No Code Available (3191)
Date of Event	04/23/2016
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 (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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female who underwent primary breast augmentation with 445cc mentor memorygel breast implants experienced fatigue, brain fog, memory loss, muscle pain, joint pain, premature aging, weight gain, inflammation, vision changes, hormone imbalance, low libido, irritable bowel syndrome, hot flashes, daily migraines, heart palpitations, burning sensation under the skin in both breasts, fibromyalgia, arthritis, and random breast soreness.There is no information indicating this case was confirmed by a healthcare professional.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.See 1645337-2019-11265 for contralateral prosthesis report.
Additional Manufacturer Narrative
On 5/7/2019 mentor became aware that the initial report submitted on this same date had a portion of section b that was erroneously omitted.The following correction has been made.2.Is other serious-check.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on 06/07/2019.The event date has been updated to (b)(6) 2016.The patient's age at the time of the event has been updated to 38.The device was explanted on (b)(6) 2019.All reported symptoms were stated to have improved.1.Is other serious-uncheck.2.Is required intervention-check.This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s psr exemption #e2007003.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: 8587827
• Report Number: 1645337-2019-11258
• Device Sequence Number: 1639319
• Product Code: FTR
• UDI-Device Identifier: 00081317004462
• UDI-Public: 00081317004462
• Combination Product (Y/N): N
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2019

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: 07/31/2017
• Device Catalogue Number: 3544457MC
• Device Lot Number: 6613119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/07/2019; 06/07/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/07/2019; 07/17/2019
• 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; Required Intervention
• Patient Age: 40 YR