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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 Name
SMOOTH SALINE BREAST IMPLANTS
Type of Device
SMOOTH SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6669668
MDR Text Key78602922
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/24/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age32 YR
Patient Weight52
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