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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS

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MENTOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS Back to Search Results
Event Date 01/01/2007
Event Type  Injury  
Event Description

(b)(4). I actually started feeling ill within a year of my implants. I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc. None of which i had before implants.

 
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Brand NameMENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7215051
Report NumberMW5074780
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
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

Patient TREATMENT DATA
Date Received: 01/24/2018 Patient Sequence Number: 1
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