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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM ULTRA XC 1 ML ROW IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94154EC
Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104); Expulsion (2933); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2017
Event Type  malfunction  
Event Description
Further follow up with the healthcare professional noted at the beginning of the procedure, the injector felt they had to put more pressure than what they were used to for the ¿product to leave the syringe exit. ¿ needle then disconnected from the syringe and the ¿product came out all over the patient¿s skin on top as if it was a cream. ¿ injector stated they think the needles of this box were clogged.
 
Manufacturer Narrative
Device analysis: 1 empty syringe of 1. 0ml received in an opened pack with an opened tray. Without cap nor needle. No defect observed.
 
Event Description
Healthcare professional reported a syringe of juvéderm ultra¿ xc "burst" during injection. No injury was reported.
 
Manufacturer Narrative
Further information from the reporter regarding event has been requested. No additional information is available at this time. Device labeling: precautions for use: if the needle is blocked, do not increase the pressure on the plunger rod but stop the injection and replace the needle. Method of use - posology. Remove tip cap by pulling it straight off the syringe as shown in fig. 1. Then firmly push the needle provided in the box (fig. 2) into the syringe, screwing it gently clockwise. Twist once more until it is fully locked and has the needle cap in the position shown in fig. 3. If the needle cap is positioned as shown in fig 4, it is incorrectly attached. Next, remove the protective cap by holding the body of the syringe in one hand, the protective cap in the other, as shown in fig. 5, and pulling the two hands in opposite directions. Inject slowly. Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level.
 
Event Description
Healthcare professional reported a syringe of juvéderm ultra¿ xc "burst" during injection. No injury was reported.
 
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Brand NameJUVEDERM ULTRA XC 1 ML ROW
Type of DeviceIMPLANT, 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 Key6730684
MDR Text Key195002047
Report Number3005113652-2017-00729
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P050047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number94154EC
Device Lot NumberH24LA70017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/20/2017 Patient Sequence Number: 1
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