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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANT SILICONE

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MENTOR BREAST IMPLANT SILICONE Back to Search Results
Catalog Number 350-5501BC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Fatigue (1849); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Tingling (2171); Anxiety (2328); Depression (2361); Numbness (2415); Confusion/ Disorientation (2553); No Code Available (3191)
Event Date 07/29/2013
Event Type  Injury  
Event Description
Received mentor silicone breast implants on (b)(6) 2013.Have had several health issues since.Extreme fatigue, migraines, digestive issues, worsening depression/anxiety, brain fog, memory issues, hair loss, numbness and tingling in left arm and leg, breast pain, chest pain.Explanting asap.
 
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Brand Name
BREAST IMPLANT SILICONE
Type of Device
BREAST IMPLANT SILICONE
Manufacturer (Section D)
MENTOR
MDR Report Key6857663
MDR Text Key85936750
Report NumberMW5072103
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 09/09/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number350-5501BC
Device Lot Number6514842
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 Age39 YR
Patient Weight63
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