SKINVIVE BY JUVEDERM XC 2X1 ML
Report
- Report Number
- 3005113652-2023-00862
- Event Type
- Injury
- Date Received
- October 31, 2023
- Date of Event
- October 18, 2023
- Report Date
- February 2, 2024
- Manufacturer
- ALLERGAN (PRINGY)
- Product Code
- LMH
- UDI-DI
- 10840228300066
- PMA / PMN Number
- P110033
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
CLARIFICATION TO SECTION C. SUSPECT PRODUCT: LOT NUMBER 963/3. CONTINUED H.6. INVESTIGATION CODE: B15, B17, B20. 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. 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.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, A6, B5, B7, E1, H6, H8.
CORRECTION TO G.3.: AWARE DATE WAS SENT AS 19/OCT/2023 IN THE LAST MEDWATCH SUBMISSION. HOWEVER, THE CORRECT AWARE DATE SHOULD BE 18/JAN/2024.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6.
HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 1ML OF SKINVIVE¿ BY JUVÉDERM® INTO EACH CHEEK AND EXPERIENCED A "VO". THE NEXT DAY, PATIENT RETURNED TO THE PRACTICE WITH NO CAP REFILL RATE AND BLANCHING. HYLENEX WAS ADMINISTERED TWICE. EVENT STATUS UNKNOWN.
ADDITIONAL DETAILS RECEIVED NOTING THAT THE HYLENEX INJECTIONS OCCURRED THE DAY EVENT STARTED AND NEXT DAY. PATIENT ALSO RECEIVED MASSAGE, WARM COMPRESS, ASPIRIN, AND NITRO PASTE ON THESE DATES. EVENT RESOLVED.
HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 1ML OF SKINVIVE¿ BY JUVÉDERM® INTO EACH CHEEK AND EXPERIENCED A "VO". THE NEXT DAY, PATIENT RETURNED TO THE PRACTICE WITH NO CAP REFILL RATE AND BLANCHING. HYLENEX WAS ADMINISTERED TWICE. EVENT STATUS UNKNOWN. ADDITIONAL DETAILS RECEIVED NOTING THAT THE HYLENEX INJECTIONS OCCURRED THE DAY EVENT STARTED AND NEXT DAY. PATIENT ALSO RECEIVED MASSAGE, WARM COMPRESS, ASPIRIN, AND NITRO PASTE ON THESE DATES. EVENT RESOLVED.
HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH 1ML OF SKINVIVE¿ BY JUVÉDERM® INTO EACH CHEEK AND EXPERIENCED A "VO". THE NEXT DAY, PATIENT RETURNED TO THE PRACTICE WITH NO CAP REFILL RATE AND BLANCHING. HYLENEX WAS ADMINISTERED TWICE. EVENT STATUS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2091548 | SKINVIVE BY JUVEDERM XC 2X1 ML | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | ALLERGAN (PRINGY) | 1000524563 | 10840228300066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Required Intervention| O |