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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMALL ROUND SALINE FILLED MAMMARY PROSTHESIS BREAST IMPLANT

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MENTOR SMALL ROUND SALINE FILLED MAMMARY PROSTHESIS BREAST IMPLANT Back to Search Results
Model Number 350-1645
Device Problem Insufficient Information (3190)
Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Inflammation (1932); Pain (1994); Rash (2033); Tinnitus (2103); Vertigo (2134); Burning Sensation (2146); Tingling (2171); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Cognitive Changes (2551); Patient Problem/Medical Problem (2688)
Event Date 04/28/2009
Event Type  Injury  
Event Description
Chronic fatigue, inflammation, insomnia, cognitive dysfunction, skin rashes, headaches, sore and aching joints of shoulders, hips, backbone, hands and feet. Anxiety, depression, and panic attacks, pain and/or burning sensation around implant and/or underarm, cold and discolored limbs, hands and feet, general chest discomfort. Shortness of breath, frequent urination, numbness/tingling sensations in upper and lower limbs, ear ringing, sudden food intolerance and allergies, vertigo.
 
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Brand NameSMALL ROUND SALINE FILLED MAMMARY PROSTHESIS
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6653071
Report NumberMW5070491
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 06/18/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number350-1645
Device Catalogue Number259156
Device Lot Number261780
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Patient Age42 YR
Patient Weight59
Patient Outcome(s) Other; Required Intervention; Disability;
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