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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN NATRELLE 68HP
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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 NameNATRELLE 68HP
Type of DeviceNATRELLE 68HP
Manufacturer (Section D)
ALLERGAN
MDR Report Key6669446
Report NumberMW5070632
Device Sequence Number1
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
Date FDA Received06/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Patient Age47 YR
Patient Weight59
Patient Outcome(s) Other;
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