MAUDE Adverse Event Report: MENTOR MENTOR SALINE IMPLANT 1600

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.

• Brand Name: MENTOR SALINE IMPLANT 1600
• Type of Device: MENTOR SALINE IMPLANT 1600
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6900055
• MDR Text Key: 87762473
• Report Number: MW5072504
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability