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MAUDE Adverse Event Report: ALLERGAN JUVEDERM
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ALLERGAN JUVEDERM
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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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Submit an Adverse Event Report
Brand Name
JUVEDERM
Type of Device
JUVEDERM
Manufacturer
(Section D)
ALLERGAN
MDR Report Key
6961133
MDR Text Key
89838477
Report Number
MW5072835
Device Sequence Number
1
Product Code
LMH
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
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
Is this an Adverse Event Report?
Yes
Is this a Product Problem Report?
No
Device Operator
No Information
Was Device Available for Evaluation?
No
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
10/19/2017
Was Device Evaluated by Manufacturer?
No Information
Type of Device Usage
N
Patient Sequence Number
1
Patient Outcome(s)
Disability;
Patient Age
40 YR
Patient Weight
51
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