JUVEDERM VOLBELLA W/LIDO 2X1ML ROW
Report
- Report Number
- 3005113652-2021-03468
- Event Type
- Injury
- Date Received
- December 15, 2021
- Date of Event
- November 29, 2021
- Report Date
- January 11, 2022
- Manufacturer
- ALLERGAN (PRINGY)
- Product Code
- LMH
- PMA / PMN Number
- P110033
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.
(B)(4). FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF VASCULAR OCCLUSION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. 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 IN THE NOSE WITH 0.3 ML OF JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE. THE PATIENT WAS CONCOMITANTLY INJECTED BETWEEN THE EYEBROWS 3 POINTS WITH 15 U OF BOTOX®. DURING THE INJECTION ON THE LEFT SIDE NEAR THE NASAL ALAR, THE PATIENT EXPERIENCED ¿CHANGE OF COLORATION TO VIOLET, 10 MINUTES LATER IT BECAME DARKER IN ASCENDING NASAL ALAR AND TOWARDS THE LEFT MALAR AND NASAL PAIN IN THE FOLLOWING DAYS.¿ DURING HOUR 2, THE PATIENT WAS TREATED WITH 1 ML OF HYALURONIDASE. DURING HOUR 3, THE PATIENT WAS GIVEN NITROGLYCERIN PATCHES, LEVOFLOXACIN 500 MG, PENTOXIFYLLINE 200, ASPIRIN 500, CLOPIDOGREL 75, DANFEN 10. DURING HOUR 4, AN ENDOSCOPY WAS PERFORMED THAT SHOWED ¿LIMITED DAMAGE.¿ DURING FOLLOW UP, THE PATIENT WAS GIVEN HYPERBARIC CHAMBER FOR 12 DAYS, 4 DAYS PATCH CHANGE, LEVOFLOXACIN 500 MG, PENTOXIFYLLINE 200, ASPIRIN 125, CLOPIDOGREL 75, DANFEN 10 AND IT WAS NOTED THAT THERE WAS ¿REVERSAL AND LEFT ALAR AND TIP WITH PURPLISH COLORATION.¿ THE EVENT IS ONGOING.
HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE NOSE WITH 0.3 ML OF JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE. THE PATIENT WAS CONCOMITANTLY INJECTED BETWEEN THE EYEBROWS 3 POINTS WITH 15 U OF BOTOX®. DURING THE INJECTION ON THE LEFT SIDE NEAR THE NASAL ALAR, THE PATIENT EXPERIENCED ¿CHANGE OF COLORATION TO VIOLET, 10 MINUTES LATER IT BECAME DARKER IN ASCENDING NASAL ALAR AND TOWARDS THE LEFT MALAR AND NASAL PAIN IN THE FOLLOWING DAYS.¿ DURING HOUR 2, THE PATIENT WAS TREATED WITH 1 ML OF HYALURONIDASE. DURING HOUR 3, THE PATIENT WAS GIVEN NITROGLYCERIN PATCHES, LEVOFLOXACIN 500 MG, PENTOXIFYLLINE 200, ASPIRIN 500, CLOPIDOGREL 75, DANFEN 10. DURING HOUR 4, AN ENDOSCOPY WAS PERFORMED THAT SHOWED ¿LIMITED DAMAGE.¿ DURING FOLLOW UP, THE PATIENT WAS GIVEN HYPERBARIC CHAMBER FOR 12 DAYS, 4 DAYS PATCH CHANGE, LEVOFLOXACIN 500 MG, PENTOXIFYLLINE 200, ASPIRIN 125, CLOPIDOGREL 75, DANFEN 10 AND IT WAS NOTED THAT THERE WAS ¿REVERSAL AND LEFT ALAR AND TIP WITH PURPLISH COLORATION.¿ THE EVENT IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1911392 | JUVEDERM VOLBELLA W/LIDO 2X1ML ROW | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | ALLERGAN (PRINGY) | V15LB10202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female | Required Intervention| O | BOTOX®. |