MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS 3000 ROUND HILE PROFILE

Catalog Number	REF 350-3380
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Chest Pain (1776); Fatigue (1849); Hair Loss (1877); Inflammation (1932); Pain (1994); Rash (2033); Tinnitus (2103); Vertigo (2134); Anxiety (2328); Depression (2361); Palpitations (2467); Weight Changes (2607)
Date of Event	12/01/2005
Type of Reportable Event	Serious Injury
Event or Problem Description
I began having rheumatoid symptoms - inflammation, huge knots popping up in various joints, pain on level 10.Had vertigo for over a year, tinnitus, debilitating fatigue, depression, anxiety hair loss, weight gain and loss for no apparent reason, heart palpitations and chest pain, rashes, shingles x3 over the past year.

• Brand Name: BREAST IMPLANTS 3000 ROUND HILE PROFILE
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6893883
• Report Number: MW5072419
• Device Sequence Number: 613836
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/24/2017
• 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 Catalogue Number: REF 350-3380
• Device Lot Number: 244699
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Weight: 64