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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 10512-600MP (RIGHT SIDE)
Device Problems Folded (2630); Material Deformation (2976)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 03/18/2013
Event Type  Injury  
Event Description
Implant has folded inside my body creating significant ripping, deformity and pain.
 
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Brand NameSIENTRA SILICONE GEL BREAST IMPLANT
Type of DeviceSILICONE GEL BREAST IMPLANT
Manufacturer (Section D)
SIENTRA, INC.
MDR Report Key4114520
MDR Text Key4939472
Report NumberMW5038298
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 09/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number10512-600MP (RIGHT SIDE)

Patient Treatment Data
Date Received: 09/17/2014 Patient Sequence Number: 1
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