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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH ROUND HIGH PROFILE GEL

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MENTOR MENTOR SMOOTH ROUND HIGH PROFILE GEL Back to Search Results
Model Number 350-3754BC
Event Date 05/05/2014
Event Type  Injury  
Event Description

Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings. Painful joints (most hands, knees, hips, shoulders) bone pain swelling of hands, tight skin. Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues. Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc). Stomach issues: burning in lower abdomen, reflux heart races, chest pains, (stabbing pain , both sides). Shortness of breath (feel like i can't catch my breath). Constant lower back pain (and right hip). Extreme smell sensitivity and intolerance of foods i used to eat. Difficulty healing (wound etc. ) dizziness (light headedness).

 
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Brand NameMENTOR
Type of DeviceSMOOTH ROUND HIGH PROFILE GEL
Manufacturer (Section D)
MENTOR
goleta CA 93117
MDR Report Key6989871
Report NumberMW5073035
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/26/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number350-3754BC
Device LOT Number6524088
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/31/2017 Patient Sequence Number: 1
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