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

Catalog Number	3542357MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor psr reference number (b)(4).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: n/a.Manufacturer¿s reference number: (b)(4).This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s psr exemption #e2007003.
Event or Problem Description
This report contains supplemental information for mentor psr reference number (b)(4).This event was previously reported to the fda under mw5084887.It was reported that a (b)(6) year old caucasian female patient who underwent primary breast augmentation with 235cc mentor memorygel breast implant experienced mood swings, anxiety, depression, weight gain, sciatica, leg pain, cognitive dysfunction, brittle finger nails, fatigue upper abdomen pain, gi/digestive issues, oral thrush, chest pain, decrease in motor functions, blurry vision, dry skin, body acne, insomnia, tinnitus, candida, muscle cramping, twitching, charlie horses in left calf, breast pain, slow wound healing, full body inflammation, suicidal thoughts, migraines, premenstrual dysphoric disorder and headaches post procedure.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the left sided device.

• 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: 9195372
• Report Number: 1645337-2019-21835
• Device Sequence Number: 13565311
• Product Code: FTR
• UDI-Device Identifier: 00081317004363
• UDI-Public: 00081317004363
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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: 07/14/2021
• Device Catalogue Number: 3542357MC
• Device Lot Number: 7353561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 10/16/2019
• 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: 44 YR
• Patient Weight: 57