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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA, INC. SIENTRA SILICONE GEL IMPLANTS
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SIENTRA, INC. SIENTRA SILICONE GEL IMPLANTS Back to Search Results
Health Effect - Clinical Codes Bacterial Infection (1735); Fatigue (1849); Feeding Problem (1850); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Pain (1994); Raynauds Phenomenon (2034); Scleroderma (2062); Vertigo (2134); Visual Disturbances (2140); Tingling (2171); Arthralgia (2355); Numbness (2415); No Code Available (3191)
Date of Event 02/19/2014
Type of Reportable Event Serious Injury
Event or Problem Description
Sientra implants on (b)(6) 2014.Since implants i have had biotoxin illness symptoms including but not limited to visual disturbances, vertigo, hair loss, nutritional deficiencies, memory loss, brain fog, pain in joints, migraines, fatigue, reynards syndrome, low ferritin levels, immune system lowered, increase food allergies, scleredema, candida overgrowth, bacterial infections in vagina, cold hands and feet, numb and tingling hands and feet, pain in shoulders, inability to concentrate.
 
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Brand Name
SIENTRA SILICONE GEL IMPLANTS
Common Device Name
SIENTRA SILICONE GEL IMPLANTS
Manufacturer (Section D)
SIENTRA, INC.
MDR Report Key5445160
Report NumberMW5060252
Device Sequence Number344322
Product Code FTR
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2016
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 02/15/2016
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 Health Professional
Other Device ID Number20621-485MP
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/15/2016
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
Patient Age34 YR
Patient Weight63
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