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

Catalog Number 94154ED

Device Problem Detachment Of Device Component (1104)

Patient Problem Blood Loss (2597)

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The event of mild bleeding is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device history record summary: the release step combined with the absence of any deviation shows that no element could explain these issues: all the syringes are inspected individually after filling and no problem was detected.There were no non conformities with the different elements of the syringes (syringe, plunger, plunger rod, tip cap, finger grip).All the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.The extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.Device labeling for the reported events of detachment of device component and blood loss: "precautions for use: patients on anti-coagulation medication or using substances that can prolong bleeding (warfarin, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, or other substances known to increase coagulation time such as herbal supplements with garlic or ginkgo biloba, etc.) must be warned of the potential increased risks of bleeding and haematomas during injection.Method of use ¿ posology: remove tip cap by pulling it straight off the syringe.Then firmly push the needle provided in the box into the syringe, screwing it gently clockwise.Twist once more until it is fully locked.Next, remove the protective cap by holding the body of the syringe in one hand, the protective cap in the other, and pulling the two hands in opposite directions.Prior to injecting, depress the plunger rod until the product flows out of the needle.Inject slowly and apply the least amount of pressure necessary.If the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.Failure to comply with these precautions could cause a disengagement of the needle and/or product leakage at luer-lock level and/or increase the risk of vascular compromise.¿ after needle insertion and before injection, it is recommended to withdraw slightly the plunger to aspirate and verify the needle is not intravascular.".

Event Description

Healthcare professional reported having a syringe of juvéderm ultra® xc where the "needle dislodge and went thru patient's lip." the packaged needle was used.The patient had mild bleeding as a result of the event.Healthcare professional took the needle out and opened new syringe to inject the patient.The patient is ok.

Manufacturer Narrative

Lab analysis: visual analysis of the returned device noted no defect was observed.

Event Description

Healthcare professional reported having a syringe of juvéderm ultra® xc where the "needle dislodge and went thru patient's lip." the packaged needle was used.The patient had mild bleeding as a result of the event.Healthcare professional took the needle out and opened new syringe to inject the patient.The patient is ok.

• Brand Name: JUVEDERM ULTRA XC (1 ML COC)
• 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
• 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 Key: 6584367
• MDR Text Key: 75792621
• Report Number: 3005113652-2017-00373
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 94154ED
• Device Lot Number: H24LA60076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR