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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA, INC. BREAST IMPLANT

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SIENTRA, INC. BREAST IMPLANT Back to Search Results
Model Number 10521-655HP
Device Problems Material Discolored (1170); Dent in Material (2526)
Patient Problem No Code Available (3191)
Event Date 09/02/2015
Event Type  Injury  
Event Description
Patient had bilateral breast implants inserted (b)(6) 2015. Returned to surgery for revision on left breast. Clinically per surgeon stated, "breast had indentation, "concave" appearance. Upon removal implant was "white and cloudy" and "more dented than usual". Possible manufacture defect.
 
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Brand NameBREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
SIENTRA, INC.
santa barbara CA 93117
MDR Report Key5064117
MDR Text Key25290216
Report NumberMW5056031
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2015
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10521-655HP
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 09/03/2015 Patient Sequence Number: 1
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