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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS

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MENTOR SILICONE BREAST IMPLANTS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Neck Pain (2433); Sleep Dysfunction (2517)
Event Date 10/01/2007
Event Type  Injury  
Event Description
I have been ill since having silicone implants - fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back.I have had 5 surgeries for shoulders and 2 on my hands.After having the breast implants removed on (b)(6) all the pain and disorders are gone.
 
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Brand Name
SILICONE BREAST IMPLANTS
Type of Device
SILICONE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6996121
MDR Text Key90969147
Report NumberMW5073098
Device Sequence Number1
Product Code FTR
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 10/31/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/02/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention;
Patient Age61 YR
Patient Weight73
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