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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA SIENTRA BREAST IMPLANTS

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SIENTRA SIENTRA BREAST IMPLANTS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 11/04/2014
Event Type  Injury  
Event Description
After two months of switching saline to seintra "gummies", i have become very sick.
 
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Brand NameSIENTRA BREAST IMPLANTS
Type of DeviceSIENTRA BREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key5324496
MDR Text Key34321940
Report NumberMW5058703
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 12/19/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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