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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
Lot Number 5728780
Device Problem Insufficient Information (3190)
Patient Problems Fatigue (1849); Hair Loss (1877); Headache (1880); Unspecified Infection (1930); Memory Loss/Impairment (1958); Swelling (2091); Visual Impairment (2138); Vomiting (2144); Complaint, Ill-Defined (2331); Sore Throat (2396); Skin Inflammation (2443); Weight Changes (2607); No Code Available (3191)
Event Date 10/01/2015
Event Type  Injury  
Event Description
Hair was falling out, constantly getting sick with sinus issues - cold, cough, infections, strep, sore throat, brain fog, tired, low libido.Arthritis in my hands, swollen feeling, vision issues, hypothyroid, hashimoto, crepe like/dry skin.Cold feet, swollen tongue, sore breast, migraines/throw up, perioral dermitis, weight gain.Have had multiple visits to the ent and walk in clinic.Have had blood tests where discovered i had thyroid issues and then found out i had hashimoto.My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness - 1 side.Going to dermatologist in a week to check extreme perioral dermatitis.Smooth mpp gel mammary prosthesis.
 
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Brand Name
SILICONE BREAST IMPLANTS
Type of Device
SILICONE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6940484
MDR Text Key89251112
Report NumberMW5072708
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 10/09/2017
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
Device Lot Number5728780
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/11/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Weight74
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