• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA BREAST IMPLANTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BREAST IMPLANTS
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key6972064
MDR Text Key90170096
Report NumberMW5072916
Device Sequence Number2
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 No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age54 YR
Patient Weight64
-
-