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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA BREAST IMPLANTS

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SIENTRA BREAST IMPLANTS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Capsular Contracture (1761); Rash (2033); Depression (2361); Skin Inflammation (2443); Cognitive Changes (2551); No Code Available (3191)
Event Type  Injury  
Event Description
Breast implants, capsule contracture, fluid in breasts, rashes, brain fog, depression. I have had depression since the implants and very bad eczema, dry hair and skin and other health symptoms.
 
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Brand NameBREAST IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key6972064
MDR Text Key90170096
Report NumberMW5072916
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/22/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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 Treatment Data
Date Received: 10/24/2017 Patient Sequence Number: 1
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