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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON/ MENTOR MENTOR SMOOTH ROUND BREAST IMPLANTS

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JOHNSON AND JOHNSON/ MENTOR MENTOR SMOOTH ROUND BREAST IMPLANTS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Muscle Spasm(s) (1966); Rash (2033)
Event Date 10/01/2010
Event Type  Injury  
Event Description
I had mentor smooth texture high profile breast implants in (b)(6) 2009 and soon after noticed changes in allergies such as throat closing after certain foods.Anaphylactic symptoms.Memory problems, disturbing enough to affect me emotionally as well.Skin rashes only getting worse and slight fibromyalgia diagnosed by dr.(b)(6).Hair thinning and lost.Muscle pains and joints.Implants are poisonous.
 
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Brand Name
MENTOR SMOOTH ROUND BREAST IMPLANTS
Type of Device
MENTOR SMOOTH ROUND BREAST IMPLANTS
Manufacturer (Section D)
JOHNSON AND JOHNSON/ MENTOR
MDR Report Key7027559
MDR Text Key91970483
Report NumberMW5073305
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/10/2017
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 Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/13/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
Patient Weight70
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