MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS (SILICONE)

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Asthma (1726); Autoimmune Reaction (1733); Fatigue (1849); Increased Sensitivity (2065); Numbness (2415); Palpitations (2467); Confusion/ Disorientation (2553); Vascular System (Circulation), Impaired (2572)
Type of Reportable Event	Serious Injury
Event or Problem Description
I had silicone breast implants from mentor in 2013.Since then i had a lot of health issues, most of them have been of autoimmune reactions involving: vascular system, neurological (brain fog, numbness in limbs), asthma, heart palpitations, extreme fatigue, hormonal issues, sensitivity to chemicals, allergies.

• Brand Name: BREAST IMPLANTS (SILICONE)
• Common Device Name: BREAST IMPLANTS (SILICONE)
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6656739
• Report Number: MW5070532
• Device Sequence Number: 1644870
• Product Code: FTR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 06/19/2017
• 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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other
• Patient Age: 26 YR
• Patient Weight: 50