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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH MODERATE PROFILE BREAST IMPLANT

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MENTOR SMOOTH MODERATE PROFILE BREAST IMPLANT Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fatigue (1849); Pain (1994); Weight Changes (2607)
Event Date 01/01/2015
Event Type  Injury  
Event Description
Sudden decline in health and increase in pain of area of implants as well as systemically.Chronic fatigue, weight gain, inability to be active.
 
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Brand Name
SMOOTH MODERATE PROFILE BREAST IMPLANT
Type of Device
SMOOTH MODERATE PROFILE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6581398
MDR Text Key75761177
Report NumberMW5069908
Device Sequence Number2
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/18/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Weight70
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