MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

Device Problem Mechanical Jam (2983)

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

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

Allergan has initiated an investigation into this late report in capa (b)(4).Device analysis summary: "no defect observed." further information from the reporter regarding event has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Device labeling: instructions for use: if the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.

Event Description

Healthcare professional reported an event of 1 syringe of juvederm® voluma xc had a malfunction, ¿the plunger would not move, and was stuck in place.¿ patient contact was made.No indication provided if there was treatment or resolution for the event.

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 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
• 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 Key: 6803986
• MDR Text Key: 83233911
• Report Number: 3005113652-2017-00775
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: (01)30888628000012(10)VB20A70200(11)170330(17)180830
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2018
• Device Catalogue Number: 94640
• Device Lot Number: VB20A70200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR