MAUDE Adverse Event Report: ALLERGAN NATRELLE 68HP

Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Chest Pain (1776); Headache (1880); Unspecified Infection (1930); Memory Loss/Impairment (1958); Skin Irritation (2076); Loss of Vision (2139); Burning Sensation (2146); Myalgia (2238); Arthralgia (2355)
Date of Event	03/14/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Breast implant in (b)(6) 2012, then i started to get around (b)(6) 2013 reoccurring infections, unexplained joint and muscle pain, severe headaches, vision and memory loss, skin issues, multiple er visits, the list goes on.Recently, (b)(6) 2017, breast and nipple pain, feeling of fire, sharp chest pain.On (b)(6) 2017 breast implant removal, due to pain.There is floaties in my saline implants and the valves are brown on inside.Definitely contaminated.Allergan natrelle 68hp saline breast implant."is the product compounded: yes; did the problem stop after the person reduced the dose or stopped taking or using the product: yes." breast augmentation.

• Brand Name: NATRELLE 68HP
• Common Device Name: NATRELLE 68HP
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 6669446
• Report Number: MW5070632
• Device Sequence Number: 1706992
• Product Code: FWM
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/24/2017
• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Weight: 59