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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Malaise (2359)
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 Name
MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7215051
MDR Text Key98084584
Report NumberMW5074780
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
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
Is the Reporter a Health Professional? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age47.000 YR
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