MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Lot Number	6646222
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hair Loss (1877); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Blurred Vision (2137); No Code Available (3191)
Date of Event	01/01/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Within a year of receiving mentor silicone high profile breast implants my health had declined tremendously.Some of the symptoms are, joint pain, muscle pain, blurry vision, ringing in the ears, hair loss, ibs, chronic fatigue, memory loss.

• Brand Name: BREAST IMPLANTS
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6560080
• Report Number: MW5069699
• Device Sequence Number: 14201414
• Product Code: FTR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 05/10/2017
• 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?: No
• Operator of Device: No Information
• Device Lot Number: 6646222
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIO IDENTICAL HORMONES; MULTIPLE VITAMINS; OTC MEDS: PROBIOTICS; RX MEDS: NEURONTIN
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 54 YR
• Patient Weight: 58