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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA, INC SIENTRA SILICONE GEL-FILLED BREAST IMPLANT
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SIENTRA, INC SIENTRA SILICONE GEL-FILLED BREAST IMPLANT Back to Search Results
Model Number 20621
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Capsular Contracture (1761)
Event Date 01/31/2014
Event Type  Injury  
Event Description
Silicone gel breast implantation - primary augmentation.Pt diagnosed with baker grade iv capsular contracture in left breast.Pt is scheduled for device removal and replacement with identical device.
 
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Brand Name
SIENTRA SILICONE GEL-FILLED BREAST IMPLANT
Manufacturer (Section D)
SIENTRA, INC
santa barbara CA
Manufacturer (Section G)
SILIMED - INDUSTRIA DE IMPLANTES LTDA
rua figueiredo geral
374 - figario geral
rio de janeiro 2124 0
BR   21240
Manufacturer Contact
joann kuhne
6769 hollister ave, ste 201
santa barbara, CA 93117
8056798879
MDR Report Key3717213
MDR Text Key4247457
Report Number1651189-2014-00007
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 Physician
Type of Report Initial
Report Date 03/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/01/2018
Device Model Number20621
Device Catalogue Number20621-415HP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/14/2014
Initial Date FDA Received03/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age56 YR
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