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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE IMPLANTS

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MENTOR MENTOR SALINE IMPLANTS Back to Search Results
Model Number 350-1655
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Fatigue (1849); Hair Loss (1877); Headache (1880); Pain (1994); Rash (2033); Complaint, Ill-Defined (2331); Palpitations (2467); Sleep Dysfunction (2517)
Event Date 01/01/2017
Event Type  Injury  
Event Description
I got breast implants and they've made me very sick.After implants, my hormone levels plummeted (i've been to specialist who could not help me) and they were 100% healthy a month before implants.I have widespread pain, heart palpitations, extreme hair loss, rashes, insomnia, chronic fatigue, migraines, edema all over, etc.I was healthy before these implants.I will explant next week to get my life back.
 
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Brand Name
MENTOR SALINE IMPLANTS
Type of Device
MENTOR SALINE IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6968220
MDR Text Key90106034
Report NumberMW5072871
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 10/19/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/23/2017
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model Number350-1655
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 Weight82
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