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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DOW CORNING / MENTOR SILICONE BREAST IMPLANT

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DOW CORNING / MENTOR SILICONE BREAST IMPLANT Back to Search Results
Model Number STYLE 235CC
Event Date 12/15/2016
Event Type  Injury  
Event Description

Believe my silicone breast implant was ruptured after a mammogram.

 
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Brand NameSILICONE BREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
DOW CORNING / MENTOR
MDR Report Key6834520
Report NumberMW5071884
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberSTYLE 235CC
Device Catalogue Number993
Device LOT NumberHH046098
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/31/2017 Patient Sequence Number: 1
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