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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 20646
Device Problem Material Rupture (1546)
Patient Problems Unspecified Infection (1930); Swelling (2091)
Event Date 03/25/2014
Event Type  Injury  
Event Description
Silicone gel breast implant - suspected rupture diagnosed by mri.Operative finding not ruptured.Second diagnosis of periprosthetic infection/fluid collection.Device replaced with identical size and style 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 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 Key3735563
MDR Text Key4277665
Report Number1651189-2014-00010
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 03/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/01/2016
Device Model Number20646
Device Catalogue Number20646-320RB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2011
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 Age43 YR
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