MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANTS

Device Problem Insufficient Information (3190)

Patient Problems 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)

Event Date 11/24/1997

Event Type  Injury  

Event 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
• Type of Device: SMOOTH SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6669668
• Report Number: MW5070655
• Device Sequence Number: 2
• Product Code: FMW
• 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: 06/24/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• 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 Weight: 52
• Patient Outcome(s): Hospitalization; Required Intervention; Disability