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

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.

• Brand Name: VOLUMA XC JUVEDERM
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 9818177
• MDR Text Key: 183346257
• Report Number: MW5093662
• 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: 03/06/2020

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/12/2020
• Device Lot Number: VB20A80614
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR