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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANTS

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MENTOR SMOOTH SALINE BREAST IMPLANTS Back to Search Results
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.
 
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Brand NameSMOOTH SALINE BREAST IMPLANTS
Type of DeviceSMOOTH SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6669668
Report NumberMW5070655
Device Sequence Number2
Product Code FMW
Reporter Country CodeUS
Number of Events Reported1
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 Received06/24/2017
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 Weight52
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
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