MAUDE Adverse Event Report: MENTOR SMOOTH SALINE IMPLANTS

Lot Number	6425763
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Anxiety (2328); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)
Date of Event	06/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
In 2011 at the age of (b)(6) i had a breast augmentation using mentor 3500cc smooth saline implants.Over the next 6 years i began to experience various symptoms such as daily headaches, insomnia, anxiety, and brain fog that i just wrote off at the time.By the summer of 2015 my health had took a turn for the worse.I became bedridden and only made attempts to get up to see another doctor to just get no answers to my sudden health decline that felt like i was dying some days.

• Brand Name: SMOOTH SALINE IMPLANTS
• Common Device Name: SMOOTH SALINE IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6456465
• Report Number: MW5068879
• Device Sequence Number: 17201951
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 03/31/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Lot Number: 6425763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADDERALL; D3; EPSOM SALT SOAKS; MAGNESIUM; OTC MEDS: NIACIN; PROBIOTIC; RX MEDS: EFFEXOR; VALIUM
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 26 YR
• Patient Weight: 61