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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR BREAST IMPLANT

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MENTOR MENTOR BREAST IMPLANT Back to Search Results
Model Number 350-2325
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Thyroid Problems (2102); Cognitive Changes (2551); Weight Changes (2607)
Event Date 01/04/2008
Event Type  Injury  
Event Description
Mentor saline breast implants caused hashimotos and sjogrens auto immune.Hair loss, fatigue, brain fog, weight gain.
 
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Brand Name
MENTOR BREAST IMPLANT
Type of Device
MENTOR BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6224791
MDR Text Key64029925
Report NumberMW5067035
Device Sequence Number1
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/02/2017
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 Model Number350-2325
Device Lot Number5689013
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/02/2017
Type of Device Usage N
Patient Sequence Number1
Treatment
MILK THISTLE; MULTI VITAMIN; VITAMIN D; VITAMIN K2
Patient Outcome(s) Disability;
Patient Age36 YR
Patient Weight82
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