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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 96183
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/31/2018
Event Type  malfunction  
Manufacturer Narrative
Further information regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported one syringe of juvéderm volbella® xc, had a "needle disengagement after the hub cracked".Patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.
 
Event Description
Healthcare professional reported one syringe of juvéderm volbella® xc, had a "needle disengagement after the hub cracked." patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.
 
Manufacturer Narrative
Device analysis: visual analysis of the device indicates empty syringe of 1.0 ml received with needle still attached to syringe in an opened tray.No defect observed to syringe.
 
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Brand Name
VOLBELLA WITH LIDOCAINE
Type of Device
IMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR  74370
MDR Report Key8297062
MDR Text Key134743349
Report Number3005113652-2019-00060
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/02/2020
Device Catalogue Number96183
Device Lot NumberV15LA80469
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Initial Date Manufacturer Received 01/08/2019
Initial Date FDA Received02/01/2019
Supplement Dates Manufacturer Received02/12/2019
Supplement Dates FDA Received03/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
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