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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA IMPLANTS BREAST BREAST IMPLANTS

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SIENTRA IMPLANTS BREAST BREAST IMPLANTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Hair Loss (1877); Pain (1994); Visual Impairment (2138)
Event Date 11/04/2014
Event Type  Injury  
Event Description
Two months after implant i had severe sores appear all over body, intense fatigue, swallow and breathing problems, chronic cough, hair loss, vision problems, eye pain, atheistic pain, pain in chest.
 
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Brand NameIMPLANTS BREAST
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key5267525
MDR Text Key32749435
Report NumberMW5058291
Device Sequence Number1
Product Code MRD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/01/2015
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/01/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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

Patient Treatment Data
Date Received: 12/01/2015 Patient Sequence Number: 1
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