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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH SPECTRUM SALINE IMPLANTS

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MENTOR MENTOR SMOOTH SPECTRUM SALINE IMPLANTS Back to Search Results
Lot Number 222358
Device Problem Insufficient Information (3190)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 06/01/2017
Event Type  Injury  
Event Description
I have actually been sick since 2004, but your calendar only goes back to 2007.I have breast implant illness and will be having the implants explanted very soon.I'm trying to pick a doctor now.
 
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Brand Name
MENTOR SMOOTH SPECTRUM SALINE IMPLANTS
Type of Device
MENTOR SMOOTH SPECTRUM SALINE IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6614215
MDR Text Key76839167
Report NumberMW5070182
Device Sequence Number1
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 06/02/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date05/17/2014
Device Lot Number222358
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Weight86
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