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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN JUVEDERM

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ALLERGAN JUVEDERM Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Cyst(s) (1800); Headache (1880); Hearing Impairment (1881); Unspecified Infection (1930); Rash (2033); Shock (2072); Visual Impairment (2138); Arthralgia (2355); Numbness (2415); No Code Available (3191)
Event Date 02/19/2017
Event Type  Injury  
Event Description
Headaches pressure, hearing and vision problems, sinus infection, pimples and cyst rash on my face. Ear pressure, numbness on my face, electric shock feeling, stinging on my scalp. Vascular stenosis, muscle and joint pain.
 
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Brand NameJUVEDERM
Type of DeviceJUVEDERM
Manufacturer (Section D)
ALLERGAN
MDR Report Key6961133
MDR Text Key89838477
Report NumberMW5072835
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Treatment Data
Date Received: 10/19/2017 Patient Sequence Number: 1
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