MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM ULTRA XC TSK US; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94154

Device Problems Gel Leak (1267); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported that during an injection with juvéderm® ultra xc, ¿while injecting the patient, there was more pressure than normal as if the plunger had stopped, i pulled needle out slightly, and tried to press again, and product was pushed out at the hub site".There was patient contact, and no one was injured.The packaged needle was used.

Event Description

Healthcare professional reported that during an injection with juvéderm® ultra xc, ¿while injecting the patient, there was more pressure than normal as if the plunger had stopped, i pulled needle out slightly, and tried to press again, and product was pushed out at the hub site.¿ there was patient contact, and no one was injured.The packaged needle was used.

Manufacturer Narrative

Device analysis: visual analysis of the device indicates empty syringe of 1.0 ml received with needle still attached in an opened tray & pack.1 unused needle is also present.No defect observed to syringe.

• Brand Name: JUVEDERM ULTRA XC TSK US
• 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: 8272302
• MDR Text Key: 134326790
• Report Number: 3005113652-2019-00086
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: 30888628000081
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2019
• Device Catalogue Number: 94154
• Device Lot Number: H24LA80494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR