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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 10521
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2014
Event Type  Injury  
Event Description
Silicone gel breast implant - mri indicated device rupture. Device removed and replaced with identical device.
 
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Brand NameSIENTRA SILICONE GEL-FILLED BREAST IMPLANT
Manufacturer (Section D)
SIENTRA, INC
santa barbara CA
Manufacturer (Section G)
SILIMED - INDUSTRIA DE IMPLANTES LTDA
374 - figario geral
fua figueiredo rocha
rio de janeiro 2124 0
BR 21240
Manufacturer Contact
joann kuhne
6769 hollister ave., suite 201
santa barbara, CA 93117
8056798879
MDR Report Key3852982
MDR Text Key4654808
Report Number1651189-2014-00020
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 05/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2017
Device Model Number10521
Device Catalogue Number10521-335HP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2012
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: 05/23/2014 Patient Sequence Number: 1
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