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

MAUDE Adverse Event Report: SIENTRA, INC SIENTRA SILICONE GEL-FILLED BREAST IMPLANT

  • 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, INC SIENTRA SILICONE GEL-FILLED BREAST IMPLANT Back to Search Results
Model Number 20646
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Capsular Contracture (1761)
Event Date 01/30/2014
Event Type  Injury  
Event Description
Silicone gel breast implantation - primary augmentation. Patient diagnosed with baker grade iii capsular contracture in left breast. Patient is scheduled for device removal and replacement with identical device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSIENTRA SILICONE GEL-FILLED BREAST IMPLANT
Manufacturer (Section D)
SIENTRA, INC
santa barbara CA
Manufacturer (Section G)
SILIMED - INDUSTRIA DE IMPLANTES LTDA
rua figueiredo rocha
374 - figario geral
rio de janeiro 2124 0
BR 21240
Manufacturer Contact
joann kuhne
6769 hollister ave.
suite 201
santa barbara, CA 93117
8056798879
MDR Report Key3720608
MDR Text Key4277924
Report Number1651189-2014-00009
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2018
Device Model Number20646
Device Catalogue Number20646-370RB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/25/2014 Patient Sequence Number: 1
-
-