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Super Search Devices@FDA
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ALLERGAN NATRELLE 68HP Back to Search Results
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems 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)
Event Date 03/14/2013
Event Type  Injury  
Event 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.
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key6669446
MDR Text Key78612371
Report NumberMW5070632
Device Sequence Number2
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 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
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/26/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age47 YR
Patient Weight59