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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94201JR
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2017
Event Type  malfunction  
Manufacturer Narrative
Device analysis: visual analysis of the returned device noted no defect. A review of the device history record has been completed. No deviations or non-conformances noted.
 
Event Description
Healthcare professional reported "during aspiration in the first injection site of a treatment" with juvéderm® volift¿ with lidocaine the plunger rod "was released from its elastic end in the syringe'. No patient impact. Packaged needle was used.
 
Manufacturer Narrative
Further information from the reporter regarding event, product, and patient details has been requested. No additional information is available at this time. Device labeling addresses the reported event(s) as follows: method of use - posology. Prior to injecting, depress the plunger rod until the product flows out of the needle. Inject slowly and apply the least amount of pressure necessary. After needle insertion and before injection, it is recommended to withdraw slightly the plunger to aspirate and verify the needle is not intravascular.
 
Event Description
Healthcare professional reported "during aspiration in the first injection site of a treatment" with juvéderm® volift¿ with lidocaine the plunger rod "was released from its elastic end in the syringe'. No patient impact. Packaged needle was used.
 
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Brand NameVOLIFT 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 Key6728046
MDR Text Key194995966
Report Number3005113652-2017-00769
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Catalogue Number94201JR
Device Lot NumberV17LA60574
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2016
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: 07/20/2017 Patient Sequence Number: 1
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