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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA SIENTRA BREAST IMPLANT

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SIENTRA SIENTRA BREAST IMPLANT Back to Search Results
Model Number TEXTURED ROUND AUGMENTATION
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Rash (2033)
Event Date 10/28/2015
Event Type  Injury  
Event Description
I received sientra silicone breast implants on (b)(6) 2015. The serial number of the implant was (b)(4). A week after receiving the implants the implants i developed a bumpy rash covering the whole breast area that is red and purple in color. The symptoms are still persisting in the area and have not gotten any better. I saw the news about sientra's contamination in their factories and the (b)(6) medicines and healthcare products regulatory agency suspension of sales of sientra implants. I would like to be informed if the fda has any updates regarding possible contamination of the products in the u. S. And whether these rash symptoms are a byproduct of the implants.
 
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Brand NameSIENTRA BREAST IMPLANT
Type of DeviceSIENTRA BREAST IMPLANT
Manufacturer (Section D)
SIENTRA
MDR Report Key5201170
MDR Text Key30461425
Report NumberMW5057639
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/29/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTEXTURED ROUND AUGMENTATION
Device Catalogue Number20621-415HP
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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