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U.S. Department of Health and Human Services

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

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SIENTRA, INC SILICONE GEL-FILLED BREAST IMPLANT, TX SHP RB Back to Search Results
Model Number 20646
Device Problem Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Date 06/12/2012
Event Type  Injury  
Event Description
Bilateral breast reconstruction surgery performed on (b)(6) 2012. One implant removed and replaced on (b)(6) 2012 due to seroma.
 
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Brand NameSILICONE GEL-FILLED BREAST IMPLANT, TX SHP RB
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
MDR Report Key2704036
MDR Text Key2792030
Report Number1651189-2012-00001
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 07/16/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2016
Device Model Number20646
Device Catalogue Number20646-425RB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/17/2012
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2011
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: 07/25/2012 Patient Sequence Number: 1
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