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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR HP IMPLANTS BREAST IMPLANTS

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MENTOR MENTOR HP IMPLANTS BREAST IMPLANTS Back to Search Results
Model Number 350CC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Memory Loss/Impairment (1958); Nausea (1970); Seizures (2063); Blurred Vision (2137); Tingling (2171); Dizziness (2194); Depression (2361); Cognitive Changes (2551); Confusion/ Disorientation (2553); Alteration In Body Temperature (2682)
Event Date 11/20/2016
Event Type  Injury  
Event Description
Brain fog, dizzy, memory loss, nausea, seizures, blurred vision. Tingling in hands and feet, temperatures problems, depression, confusion.
 
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Brand NameMENTOR HP IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7009576
MDR Text Key91441719
Report NumberMW5073169
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 Unknown
Type of Report Initial
Report Date 11/04/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number350CC
Device Catalogue Number350-3504
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/08/2017 Patient Sequence Number: 1
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