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

Device Problems Patient-Device Incompatibility (2682); Device Ingredient or Reagent Problem (2910)

Patient Problems Bruise/Contusion (1754); Dry Eye(s) (1814); Glaucoma (1875); Muscular Rigidity (1968); Nerve Damage (1979); Blurred Vision (2137); Taste Disorder (4422); Swelling/ Edema (4577)

Event Date 04/10/2021

Event Type  Injury  

Event Description

I received dermal fillers (juvederm) product in my lips by a doctor, when she administered the fillers a few hours i had mild swelling and bruising.However two months later, i got a reaction that was abnormal which left my face muscles and lip area immobile.I could not taste, and could not move my lips because they were hard as a rock.When i went back to the doctor's office, she gave me steroids' and antihistamines, but my lips only got worse.I ended up in the emergency room, and was given antibiotics.The swelling was so severe, she decided to dissolve the lip filler at this point.After when she did, the enzyme in the dissolving agent (hyaluronidase) only made things worse for my body and lips.I now need reconstructive surgery on my lip to get the agent and filler out of my lip, it has caused permanent damage for the rest of life on my lip.Also damage to the nerves around that area.I have been admitted to the emergency room again because my tongue got stiff and hard had almost seizure like symptoms.I suffered extreme eye dryness, eye pressure, and blurriness so i went to the eye doctor and might have glaucoma.

• Brand Name: JUVEDERM VOLBELLA
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 11796812
• MDR Text Key: 249970803
• Report Number: MW5101245
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• 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: 05/06/2021

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: 05/07/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 24 YR