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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
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems 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)
Event Date 02/19/2014
Event Type  Injury  
Event 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
Type of Device
SIENTRA SILICONE GEL IMPLANTS
Manufacturer (Section D)
SIENTRA, INC.
MDR Report Key5445160
MDR Text Key38539559
Report NumberMW5060252
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 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
Device Operator Health Professional
Other Device ID Number20621-485MP
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/15/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age34 YR
Patient Weight63
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