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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE GEM IMPLANT; BREAST IMPLANT

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MENTOR SMOOTH ROUND MODERATE PLUS PROFILE GEM IMPLANT; BREAST IMPLANT Back to Search Results
Model Number 350-3251BC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Unspecified Infection (1930); Immunodeficiency (2156); Joint Disorder (2373); Neck Pain (2433)
Event Date 08/12/2013
Event Type  Injury  
Event Description
Began with pain in joints/muscles of the neck, led to other infections and weakened immune system, followed by growing pain in joints and extreme fatigue.
 
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Brand Name
SMOOTH ROUND MODERATE PLUS PROFILE GEM IMPLANT
Type of Device
BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6459767
MDR Text Key71907636
Report NumberMW5068891
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/04/2017
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
Device Model Number350-3251BC
Device Lot Number5947419
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/04/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
OTC MEDS: MULTIVITAMIN; PROBIOTIC; RX MEDS: NA
Patient Outcome(s) Disability;
Patient Age45 YR
Patient Weight59
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