MAUDE Adverse Event Report: MENTOR SMALL ROUND SALINE FILLED MAMMARY PROSTHESIS; BREAST IMPLANT

Model Number	350-1645
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Headache (1880); Inflammation (1932); Pain (1994); Rash (2033); Tinnitus (2103); Vertigo (2134); Burning Sensation (2146); Tingling (2171); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Cognitive Changes (2551); Patient Problem/Medical Problem (2688)
Date of Event	04/28/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet.Anxiety, depression, and panic attacks, pain and/or burning sensation around implant and/or underarm, cold and discolored limbs, hands and feet, general chest discomfort.Shortness of breath, frequent urination, numbness/tingling sensations in upper and lower limbs, ear ringing, sudden food intolerance and allergies, vertigo.

• Brand Name: SMALL ROUND SALINE FILLED MAMMARY PROSTHESIS
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6653071
• Report Number: MW5070491
• Device Sequence Number: 1658621
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 06/18/2017
• 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 Model Number: 350-1645
• Device Catalogue Number: 259156
• Device Lot Number: 261780
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 42 YR
• Patient Weight: 59