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

Catalog Number 94154EC

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

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: "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

Company representative reports on behalf of a healthcare professional the event of a "defected syringe".It was reported that a syringe of juvéderm ultra xc was loose during injection.

Event Description

Company representative reports on behalf of a healthcare professional the event of a "defected syringe." it was reported that a syringe of juvéderm ultra xc was loose during injection.

Manufacturer Narrative

Device evaluation: lab analysis of the device found 1 empty syringe of 1.0ml received in an opened pack with an opened tray.Received without cap but with one needle attached.No defect observed.

• 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
• MDR Report Key: 8075232
• MDR Text Key: 128042314
• Report Number: 3005113652-2018-01552
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 94154EC
• Device Lot Number: H24LA70353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR