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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE BREAST IMPLANTS

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MENTOR MENTOR SALINE BREAST IMPLANTS Back to Search Results
Model Number REF 350-1650
Device Problem Insufficient Information (3190)
Patient Problems Fatigue (1849); Pain (1994); Complaint, Ill-Defined (2331); Neck Pain (2433)
Event Date 03/17/2004
Event Type  Injury  
Event Description
I have been feeling terrible for at least the last ten years or more.I've seen drs, had tests, multiple lyme and blood tests, xrays, been to physical therapy but nothing.I have chronic symptoms such as bone pain, neck and back pain, brain fog, severe fatigue that affects my concentration and driving, stomach and digestive issues, and eye problems, etc.Among many symptoms that make me feel like i'm dying a slow death.I have come to learn that these symptoms are all from the mentor saline implants done back in (b)(6) 2004, which i cannot afford to have removed.Functioning in life is difficult and painful.My quality of life is very poor.
 
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Brand Name
MENTOR SALINE BREAST IMPLANTS
Type of Device
MENTOR SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7209059
MDR Text Key97959673
Report NumberMW5074696
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/17/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberREF 350-1650
Device Lot Number271355
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Weight59
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