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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS

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MENTOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Fatigue (1849); Pain (1994)
Event Date 04/01/2008
Event Type  Injury  
Event Description
(b)(4).Chronic fatigue, body pain, brain fog, dry eyes.
 
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Brand Name
MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6533711
MDR Text Key74054711
Report NumberMW5069456
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age43.000 YR
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