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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ MENTOR MENTOR SMOOTH ROUND BREAST IMPLANTS

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JOHNSON AND JOHNSON/ MENTOR MENTOR SMOOTH ROUND BREAST IMPLANTS Back to Search Results
Event Date 10/01/2010
Event Type  Injury  
Event Description

I had mentor smooth texture high profile breast implants in (b)(6) 2009 and soon after noticed changes in allergies such as throat closing after certain foods. Anaphylactic symptoms. Memory problems, disturbing enough to affect me emotionally as well. Skin rashes only getting worse and slight fibromyalgia diagnosed by dr. (b)(6). Hair thinning and lost. Muscle pains and joints. Implants are poisonous.

 
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Brand NameMENTOR SMOOTH ROUND BREAST IMPLANTS
Type of DeviceMENTOR SMOOTH ROUND BREAST IMPLANTS
Manufacturer (Section D)
JOHNSON AND JOHNSON/ MENTOR
MDR Report Key7027559
Report NumberMW5073305
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/10/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received11/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? Yes
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: 11/13/2017 Patient Sequence Number: 1
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