• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALLERGAN (PRINGY) JUVEDERM ULTRA XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94154
Device Problems Gel Leak (1267); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2018
Event Type  malfunction  
Manufacturer Narrative
Further information regarding event, product, or patient details has been requested. No additional information is available at this time. Device labeling addresses the reported event(s) as follows: 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. Health care professional instructions 9. If the needle is blocked, do not increase the pressure on the plunger rod. Instead, stop the injection and replace the needle.
 
Event Description
Health professional reported that during injection with juvéderm® ultra xc the "product was not flowing out properly even though pressure was applied¿ and the needle "popped off and the product was lost. " no injury to the patient or injector. The packaged needle was used.
 
Event Description
Health professional reported that during injection with juvéderm® ultra xc the "product was not flowing out properly even though pressure was applied¿ and the needle "popped off and the product was lost. " no injury to the patient or injector. The packaged needle was used.
 
Manufacturer Narrative
Device analysis: empty syringe of 1. 0 ml received without cap, no syringe. No defect observed to syringe.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameJUVEDERM ULTRA XC TSK US
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
MDR Report Key7360235
MDR Text Key103178388
Report Number3005113652-2018-00288
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/29/2018
Device Catalogue Number94154
Device Lot NumberH24LA70331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/21/2018 Patient Sequence Number: 1
-
-