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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE

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DERMAL FILLER IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Swelling (2091); Reaction (2414)
Event Date 11/10/2020
Event Type  Injury  
Event Description
Bought botox (botulax) and a dermal filler online at (b)(6). Had swelling and nerve damage in my face. (b)(6). Fda safety report id# (b)(4).
 
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Brand NameDERMAL FILLER
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
MDR Report Key11385177
MDR Text Key234100946
Report NumberMW5099667
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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: 02/25/2021 Patient Sequence Number: 1
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