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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
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Codes 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)
Type of Reportable Event Serious Injury
Event or Problem 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 Name
MENTOR SALINE IMPLANT 1600
Common Device Name
MENTOR SALINE IMPLANT 1600
Manufacturer (Section D)
MENTOR
MDR Report Key6900055
Report NumberMW5072504
Device Sequence Number506053
Product Code FWM
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2001
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 09/26/2017
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
Operator of Device Health Professional
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/27/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Other; Required Intervention; Disability;
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