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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANT; PROSTHESIS, BREAST, NON INFLATABLE SILICONE GEL

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MENTOR BREAST IMPLANT; PROSTHESIS, BREAST, NON INFLATABLE SILICONE GEL Back to Search Results
Model Number 350-6004BC
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Arthritis (1723); High Blood Pressure/ Hypertension (1908); Lupus (1956); Pain (1994); Sjogren's Syndrome (2073); Discomfort (2330); Reaction (2414)
Event Date 06/19/2017
Event Type  malfunction  
Event Description
I will be having my silicone implants removed.After several years of pain and discomfort and being diagnosed with sjogren's syndrome, lupus, arthritis, fibromyalgia, high blood pressure, my plastic surgeon recommends the removal of my implants.This is so my body can have an opportunity to try and heal and settle down from all of the reactions my body is experiencing.The implants are scheduled to be removed on (b)(6).Other diagnosis are for fibromyalgia due to the chronic pain i suffer.
 
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Brand Name
BREAST IMPLANT
Type of Device
PROSTHESIS, BREAST, NON INFLATABLE SILICONE GEL
Manufacturer (Section D)
MENTOR
MDR Report Key6659907
MDR Text Key78257028
Report NumberMW5070556
Device Sequence Number2
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/20/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number350-6004BC
Device Lot Number6551807
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
Patient Weight100
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