JUVEDERM VOLIFT W/LIDO 2X1ML EAME SKU1
Report
- Report Number
- 3005113652-2021-03415
- Event Type
- Injury
- Date Received
- November 22, 2021
- Date of Event
- October 25, 2021
- Report Date
- January 20, 2022
- Manufacturer
- ALLERGAN (PRINGY)
- Product Code
- LMH
- PMA / PMN Number
- P110033
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL, CORRECTED, AND/OR CHANGED DATA: B.1., B.2., H.6.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.
THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF "INFLAMMATORY NODULE" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.
HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT BILATERALLY WITH 3 SYRINGES OF JUVÉDERM® VOLIFT¿ WITH LIDOCAINE (1ML AT SOOF, 1ML AT NLF, 1ML AT ML), 3 SYRINGES OF JUVÉDERM® VOLUMA¿ (1ML AT T1, 1ML AT CK4, AND 1ML AT CK1), AND 1ML OF JUVÉDERM® ULTRA 3 IN THE LIPS. 7 MONTHS LATER, THE PATIENT PRESENTED WITH INFLAMMATORY NODULES, RUSH, AND HEAT IN THE TREATED AREAS. TREATMENT PROVIDED WITH ATB + CEB.O + IBP +HA. PATIENT BEGAN WITH OMEPRAZOLE (20 MG 1-0-0); AUGMENTIN (875 /125 MG EACH 8 HOURS), DEFLAZACORT (30 MG 0-1-0 DURING 7 DAYS). PER HEALTHCARE PROFESSIONAL, PATIENT HAD AN OUTBREAK OF "HERPES AND ACNE" IN THE "SUMMER" AND WAS TREATED WITH FOR ANTIVIRAL AND ARNICA. THE PATIENT ALSO RECEIVED THEIR COVID-19 VACCINE. SYMPTOMS ONGOING/UNRESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2021-03418 (ALLERGAN COMPLAINT (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® VOLIFT¿ WITH LIDOCAINE.
ADDITIONAL INFORMATION RECEIVED FROM HEALTHCARE PROFESSIONAL CLARIFYING THAT THE INJECTED AREA WAS "SOOF" REGION IS DEEP FAT OF EYE BAGS; "MS" REGION IS MARIONETTE LINES; AND "SNG" REGION IS NASOGENIAN FOLDS.
HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT BILATERALLY WITH 3 SYRINGES OF JUVÉDERM® VOLIFT¿ WITH LIDOCAINE (1ML AT SOOF, 1ML AT NLF, 1ML AT ML), 3 SYRINGES OF JUVÉDERM® VOLUMA¿ (1ML AT T1, 1ML AT CK4, AND 1ML AT CK1), AND 1ML OF JUVÉDERM® ULTRA 3 IN THE LIPS. 7 MONTHS LATER, THE PATIENT PRESENTED WITH INFLAMMATORY NODULES, RUSH, AND HEAT IN THE TREATED AREAS. TREATMENT PROVIDED WITH ATB + CEB.O + IBP +HA. PATIENT BEGAN WITH OMEPRAZOLE (20 MG 1-0-0); AUGMENTIN (875 /125 MG EACH 8 HOURS), DEFLAZACORT (30 MG 0-1-0 DURING 7 DAYS). PER HEALTHCARE PROFESSIONAL, PATIENT HAD AN OUTBREAK OF "HERPES AND ACNE" IN THE "SUMMER" AND WAS TREATED WITH FOR ANTIVIRAL AND ARNICA. THE PATIENT ALSO RECEIVED THEIR COVID-19 VACCINE. SYMPTOMS ONGOING/UNRESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2021-03418 (ALLERGAN COMPLAINT (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® VOLIFT¿ WITH LIDOCAINE.
HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT BILATERALLY WITH 3 SYRINGES OF JUVÉDERM® VOLIFT¿ WITH LIDOCAINE (1ML AT SOOF, 1ML AT NLF, 1ML AT ML), 3 SYRINGES OF JUVÉDERM® VOLUMA¿ (1ML AT T1, 1ML AT CK4, AND 1ML AT CK1), AND 1ML OF JUVÉDERM® ULTRA 3 IN THE LIPS. 7 MONTHS LATER, THE PATIENT PRESENTED WITH INFLAMMATORY NODULES, RUSH, AND HEAT IN THE TREATED AREAS. TREATMENT PROVIDED WITH ATB + CEB.O + IBP +HA. PATIENT BEGAN WITH OMEPRAZOLE (20 MG 1-0-0); AUGMENTIN (875 /125 MG EACH 8 HOURS), DEFLAZACORT (30 MG 0-1-0 DURING 7 DAYS). PER HEALTHCARE PROFESSIONAL, PATIENT HAD AN OUTBREAK OF "(B)(6) AND ACNE" IN THE "SUMMER" AND WAS TREATED WITH FOR ANTIVIRAL AND ARNICA. THE PATIENT ALSO RECEIVED THEIR COVID-19 VACCINE. SYMPTOMS ONGOING/UNRESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2021-03418 (ALLERGAN COMPLAINT (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® VOLIFT¿ WITH LIDOCAINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1753689 | JUVEDERM VOLIFT W/LIDO 2X1ML EAME SKU1 | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | ALLERGAN (PRINGY) | V17LB00673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Other| R | JUVÉDERM® VOLUMA¿. |