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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 94728JR
Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)
Patient Problem Not Applicable (3189)
Event Date 12/14/2016
Event Type  malfunction  
Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Device labeling addresses the reported event as follows: ¿ "do not use if the packaging is damaged. ".
 
Event Description
Healthcare professional reported "syringe was open inside the box" of juvéderm® volbella¿ with lidocaine. The reporter "wasn't sure if ok to be used as not sterile" and noted the "box was damaged. " there was no patient contact and no injury to patient or injecting nurse.
 
Manufacturer Narrative
Device history record summary: the documentary research in the batch file shows that no element could explain this issue: all the manufacturing steps are registered as conforming to the specifications. For this batch, no problem was detected. The sterilization cycle is registered as conforming for this batch. Device analysis summary: one full syringe of 1. 0ml was received in an opened pack with an opened tray. No defect was observed on the syringe.
 
Event Description
Healthcare professional reported "syringe was open inside the box" of juvéderm® volbella¿ with lidocaine. The reporter "wasn't sure if ok to be used as not sterile" and noted the "box was damaged. " there was no patient contact and no injury to patient or injecting nurse.
 
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Brand NameVOLBELLA WITH LIDOCAINE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer Contact
suzanne wojcik
301 w howard lane
suite 100
austin, TX 78753
7372473605
MDR Report Key6233013
MDR Text Key64178277
Report Number3005113652-2016-01013
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue Number94728JR
Device Lot NumberV15LA60316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/09/2017 Patient Sequence Number: 1
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