MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC 1 ML ROW; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94154EC

Device Problems Burst Container or Vessel (1074); Clumping in Device or Device Ingredient (1095); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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: "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 trying to inject a patient with a syringe of juvéderm ultra xc using the packaged needle.There was something wrong with the first needle so a 2nd needle was used.The healthcare professional pushed against the syringe and there was a lot of pressure and the product did not come out.Due to the pressure, the product did not come out smoothly and afterwards, it burst out completely all over the patient.The healthcare professional then inspected the product and found lumps in it.There were no injuries.Device had been stored in a dark cool area at room temperature.

• Brand Name: JUVEDERM ULTRA XC 1 ML ROW
• 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: 7854807
• MDR Text Key: 119498768
• Report Number: 3005113652-2018-01128
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2018

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: 02/28/2019
• Device Catalogue Number: 94154EC
• Device Lot Number: H24LA70194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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: 65 YR