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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 Name
IMPLANTS BREAST
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key5267525
MDR Text Key32749435
Report NumberMW5058291
Device Sequence Number2
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 No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age49 YR
Patient Weight62
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