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

Catalog Number 94151EC

Device Problems Use of Device Problem (1670); Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2018

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: "5.Precautions ¿ failure to comply with the needle attachment instructions could result in needle disengagement and/or product leakage at the luer-lok® and needle hub connection.".

Event Description

Healthcare professional reported that a patient was injected in the malar region for ¿volume loss¿ with 0.5 cc of juvéderm® voluma¿ with lidocaine and during the injection ¿product emerged through the place of tie with the needle.¿ there was a ¿defect in the draw of the syringe (luer lock) with the needle.¿ no injuries occurred.It was reported that the syringe was used more than once.The needle from the package was used.

Manufacturer Narrative

Lab analysis of the device found 1 empty syringe of 1.0ml received in an opened tray with cap and without needle.No defect observed.Device history record summary: all released batches are compliant with the processing steps described in the master batch and our specifications and especially the sterilization cycle was recorded as compliant.All microbiological, physical and chemical results (endotoxins, bioburden) are recorded in compliance with our specifications and especially the extrusion force value shows our product¿s expected consistency.There were no non conformities with the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).The release step combined with the absence of any deviation shows that no element could explain these issues.

Event Description

Healthcare professional reported that a patient was injected in the malar region for ¿volume loss¿ with 0.5 cc of juvéderm® voluma¿ with lidocaine and during the injection ¿product emerged through the place of tie with the needle.¿ there was a ¿defect in the draw of the syringe (luer lock) with the needle.¿ no injuries occurred.It was reported that the syringe was used more than once.The needle from the package was used.

• 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: 7640148
• MDR Text Key: 112420579
• Report Number: 3005113652-2018-00822
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 94151EC
• Device Lot Number: VB20A70834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR