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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE IMPLANT 1600

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MENTOR MENTOR SALINE IMPLANT 1600 Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Emotional Changes (1831); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Pneumonia (2011); Ulceration (2116); Anxiety (2328); Depression (2361); Mitral Valve Prolapse (2471); Pericardial Effusion (3271)
Event Type  Injury  
Event Description
Mentor saline implants in 2001. Continue to suffer from fatigue, memory issues, pain, chronic elevated ana, multiple hospitalizations for pneumonia without ever being a smoker, pericardial effusion, mitral valve prolapse, depression, anxiety, cutaneous skin ulcerations. I am desperately trying to get funds together to have them removed. I have been robbed of my ability to practice in the healthcare field, provide my children with a mother whom is both present and available. My life has been ruined! not to mention the numerous times i have attempted suicide.
 
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Brand NameMENTOR SALINE IMPLANT 1600
Type of DeviceMENTOR SALINE IMPLANT 1600
Manufacturer (Section D)
MENTOR
MDR Report Key6900055
MDR Text Key87762473
Report NumberMW5072504
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 09/26/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 09/27/2017 Patient Sequence Number: 1
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