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

Catalog Number 94155

Device Problems Crack (1135); Gel Leak (1267)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2019

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 plus xc ¿the syringe had a cracked luer lock tip, the product leaked out the side of the syringe¿.Patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.

Manufacturer Narrative

Device analysis: visual analysis of the device indicates empty syringe of 1.0 ml received without needle, no cap.A crack is observed at the 3 mm luer lock level.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.

Event Description

Healthcare professional reported that during an injection with juvéderm® ultra plus xc ¿the syringe had a cracked luer lock tip, the product leaked out the side of the syringe.¿ patient contact was made, but no injury to patient, staff, or injector.The packaged needle was used.

• Brand Name: JUVEDERM ULTRA PLUS 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: 8297154
• MDR Text Key: 134743040
• Report Number: 3005113652-2019-00090
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000111
• UDI-Public: 30888628000111
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: 94155
• Device Lot Number: H30LA80476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR