JUVEDERM VOLITE WITH LIDOCAINE 2X1 ML 95662ED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for JUVEDERM VOLITE WITH LIDOCAINE 2X1 ML 95662ED manufactured by Allergan (pringy).

MAUDE Entry Details

Report Number3005113652-2020-00142
MDR Report Key9885574
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2019-07-24
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. MICHELLE BURGESS
Manufacturer Street12331-A RIATA TRACE PARKWAY BUILDING 3
Manufacturer CityAUSTIN TX 78727
Manufacturer CountryUS
Manufacturer Postal78727
Manufacturer Phone7372473605
Manufacturer G1ALLERGAN (PRINGY)
Manufacturer StreetROUTE DE PROMERY ZONE ARTISANALE DE PRE-MAIRY
Manufacturer CityPRINGY 74370
Manufacturer CountryFR
Manufacturer Postal Code74370
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameJUVEDERM VOLITE WITH LIDOCAINE 2X1 ML
Generic NameIMPLANT, DERMAL, FOR AESTHETIC USE
Product CodeLMH
Date Received2020-03-26
Catalog Number95662ED
Lot NumberV12LA80626
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (PRINGY)
Manufacturer AddressROUTE DE PROMERY ZONE ARTISANALE DE PRE-MAIRY PRINGY 74370 FR 74370

Device Sequence Number: 101

Brand NameHYDROCHLORIDE LIDOCAINE / 0.3 %
Product Code---
Date Received2020-03-26
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-26

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