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U.S. Department of Health and Human Services

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

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SIENTRA, INC SIENTRA SILICONE GEL BREAST IMPLANT Back to Search Results
Model Number 10512
Device Problem Material Rupture (1546)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
Reported rupture of silicone gel-filled breast implant.
 
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Brand Name
SIENTRA SILICONE GEL BREAST IMPLANT
Manufacturer (Section D)
SIENTRA, INC
santa barbara CA
Manufacturer (Section G)
SILIMED-INDUSTRIALDE IMPLANTES LTDA
rua figueiredo rocha
374 - figario geral
io de janeiro 2124 0
BR   21240
Manufacturer Contact
joann kuhne
6769 hollister ave.
suite 201
santa barbara, CA 93117
8056798879
MDR Report Key3373424
MDR Text Key3934816
Report Number1651189-2013-00026
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 09/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2016
Device Model Number10512
Device Catalogue Number10512-380MP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/17/2013
Was Device Evaluated by Manufacturer? Yes
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 Sequence Number1
Patient Outcome(s) Other;
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