MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94151EC

Device Problems Break (1069); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: method of use-posology.Juvéderm® voluma¿ with lidocaine ¿ is to be used as supplied.Modification or use of the product outside the directions for use may adversely impact the sterility, homogeneity and performance of the product and it can therefore no longer be assured.

Event Description

Healthcare professional reports "central rubber that pushes the product ruptured" when trying to push the plunger of a syringe of juvéderm® voluma¿ with lidocaine.Event further explained as "when adapting the cannula to the syringe, it seemed that the screw did not adapt correctly, and broke in this attempt." patient was injected with 0.2 ml of product in "ck3." there were no injuries.

Manufacturer Narrative

Lab analysis of the device found 1 empty syringe of 1.0ml received in an opened pack with an opened tray.Without cap nor needle.No defect observed.

Event Description

Healthcare professional reports "central rubber that pushes the product ruptured" when trying to push the plunger of a syringe of juvéderm® voluma¿ with lidocaine.Event further explained as "when adapting the cannula to the syringe, it seemed that the screw did not adapt correctly, and broke in this attempt." patient was injected with 0.2 ml of product in "ck3." there were no injuries.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1ML
• 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 Key: 7953189
• MDR Text Key: 124993154
• Report Number: 3005113652-2018-01305
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

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 Date: 01/31/2020
• Device Catalogue Number: 94151EC
• Device Lot Number: VB20A80121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVÉDERM VOLBELLA WITH LIDOCAINE
• Patient Outcome(s): Other