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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN VOLUMA XC JUVEDERM IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN VOLUMA XC JUVEDERM IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Lot Number VB20A80614
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fatigue (1849); Unspecified Infection (1930); Impaired Healing (2378); Reaction (2414)
Event Date 08/07/2019
Event Type  Injury  
Event Description
I received injections ( voluma xc) from (b)(6) spa, (b)(6). Approximately 5 to 10 days later my face began to break out at every injection site. Blister like bumps appeared and a clear liquid would drain from them but they would not heal. Finally a little white object that looked like a parasite would come out, most often several of those things in each blister. Then the sore would heal. This continues to happen along my cheek area and nasal folds where i received injections. I have been extremely tired, unable to function as i normally would. I believe my body has been fighting what ever it is that is in my body. I contacted (b)(6) spa and i tried to verify their purchase of the product from the juvederm company (allergan) but i was told the info was confidential. Via photos that i sent to (b)(6) spa and their on staff dermatologist who prescribed an antibiotic. She said she wouldn't be positive what the substance was but believed it was an infection. I went to a dermatologist and she said she had never seen anything like that. She suggested that i finish the antibiotics and in a few weeks if my condition doesn't improve i should come back and see a specialist in juvederm injections. I believe that either the voluma xc, or the syringe were contaminated or the nurse failed to clean my face/ injection sites properly. I truly hope that the fda can tell me the product i received was made and purchased in the united states. I explained who i was and the info i was seeking to the customer service rep at juvederm. She ok let put you on hold, she returned after some time and informed me the info i wanted was confidential i was externally puzzled as to why she did not inform me of that at the beginning of the call. Thank you for your time. Sincerely, (b)(6) gtin (b)(4), lot vb20a80614, exp 02/12/2020.
 
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Brand NameVOLUMA XC JUVEDERM
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN
MDR Report Key9818177
MDR Text Key183346257
Report NumberMW5093662
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 03/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/12/2020
Device Lot NumberVB20A80614
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

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