UNK JUVEDERM VOLUX
Report
- Report Number
- 3005113652-2022-00666
- Event Type
- Injury
- Date Received
- October 6, 2022
- Date of Event
- October 15, 2021
- Report Date
- January 26, 2023
- Manufacturer
- ALLERGAN (PRINGY)
- Product Code
- LMH
- PMA / PMN Number
- P110033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.
CLARIFICATION TO H.6. TYPE OF INVESTIGATION CODE: THE SYRINGE HAS BEEN DISCARDED.
HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED AT ANOTHER HOSPITAL WITH 4 CC OF JUVEDERM VISTA VOLUMA XC, 2CC OF JUVEDERM VISTA VOLUX XC AND 1CC OF JUVEDERM VISTA VOLBELLA XC. FOUR MONTHS AFTER INJECTION, A LUMP APPEARED AROUND THE CHIN. TWO WEEKS LATER, LUMPS APPEARED ON THE ENTIRE CHIN, TEMPLES, CHEEKS, AND LIPS . HCP REPORTED SYMPTOMS OF HOT, SWELLING, AND EDEMA WERE PRESENT. HCP TREATED WITH SOLCORTEF 300 MG X 5 DAYS, 200 MG X 2 DAYS AND SYMPTOMS DID NOT IMPROVE. HCP AGAIN ADMINISTERED 300 MG X 3 DAYS, THEN 200 MG X 1 DAY, 100 MG X 1 DAY. AFTER THAT, PATIENT WAS PRESCRIBED PREDNISONE 10MG, ANTI-ALLERGIC AGENT, FUROSEMIDE, ANTIBIOTICS, AND GOREISAN WERE ADMINISTERED FOR ONE MONTH. PATIENT WAS ALSO TREATED WITH HYALURONIDASE INJECTION. SEVERAL MONTHS LATER, SYMPTOMS COMPLETELY RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2022-00665 (ALLERGAN COMPLAINT #(B)(4)), MDR ID# 3005113652-2022-00667 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM VISTA VOLUX XC.
HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED AT ANOTHER HOSPITAL WITH 4 CC OF JUVEDERM VISTA VOLUMA XC, 2CC OF JUVEDERM VISTA VOLUX XC AND 1CC OF JUVEDERM VISTA VOLBELLA XC. FOUR MONTHS AFTER INJECTION, A LUMP APPEARED AROUND THE CHIN. TWO WEEKS LATER, LUMPS APPEARED ON THE ENTIRE CHIN, TEMPLES, CHEEKS, AND LIPS . HCP REPORTED SYMPTOMS OF HOT, SWELLING, AND EDEMA WERE PRESENT. HCP TREATED WITH SOLCORTEF 300 MG X 5 DAYS, 200 MG X 2 DAYS AND SYMPTOMS DID NOT IMPROVE. HCP AGAIN ADMINISTERED 300 MG X 3 DAYS, THEN 200 MG X 1 DAY, 100 MG X 1 DAY. AFTER THAT, PATIENT WAS PRESCRIBED PREDNISONE 10MG, ANTI-ALLERGIC AGENT, FUROSEMIDE, ANTIBIOTICS, AND GOREISAN WERE ADMINISTERED FOR ONE MONTH. PATIENT WAS ALSO TREATED WITH HYALURONIDASE INJECTION. SEVERAL MONTHS LATER, SYMPTOMS COMPLETELY RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2022-00665 (ALLERGAN COMPLAINT #(B)(4)), MDR ID# 3005113652-2022-00667 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM VISTA VOLUX XC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2507613 | UNK JUVEDERM VOLUX | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | ALLERGAN (PRINGY) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention | JUVEDERM VISTA VOLUMA XC, VISTA VOLBELLA XC |