MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANTS

Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Fatigue (1849); Fever (1858); Muscle Weakness (1967); Pain (1994); Rash (2033); Dizziness (2194); Anxiety (2328); Complaint, Ill-Defined (2331); Numbness (2415); Palpitations (2467); No Code Available (3191)
Date of Event	11/24/1997
Type of Reportable Event	Serious Injury
Event or Problem Description
This was the month and year i started having heart palpitations, inability to exercise, chronic fatigue, numbness, neck and back pain, frequent fevers, anxiety, lightheadedness, profound muscle weakness, couldn't recover from anything, feeling like i was literally going to die.Extreme endocrine (blood sugar fluctuations).Inability to sweat.Heat and cold intolerance.Rashes and sensitivities to any lotions, perfumes.

• Brand Name: SMOOTH SALINE BREAST IMPLANTS
• Common Device Name: SMOOTH SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6669668
• Report Number: MW5070655
• Device Sequence Number: 10149356
• Product Code: FMW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1991
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 06/24/2017
• 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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 32 YR
• Patient Weight: 52