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

Catalog Number 94154

Device Problems Bent (1059); Coagulation in Device or Device Ingredient (1096); Difficult or Delayed Positioning (1157)

Patient Problem Bruise/Contusion (1754)

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

The event of "bruising" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event has been requested.No additional information is available at this time.Device labeling: precautions: juvéderm® ultra xc is packaged for single-patient use.Do not resterilize.Do not use if package is opened or damaged.Adverse events: per table 1: treatment site responses by maximum severity occurring in > 5% of subjects after initial treatment with juvéderm® ultra xc possible treatment site responses include: tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.Postmarket surveillance: the following adverse events were received from postmarket surveillance for juvéderm® ultra and ultra plus, with and without lidocaine, with a frequency of 5 events or more and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.All adverse events obtained through postmarket surveillance are listed in order of number of reports received: lack or loss of correction, inflammatory reaction, allergic reaction, infection, migration, paresthesia, vascular occlusion, necrosis, abscess, flu-like symptoms, headache, malaise, vision abnormalities, scarring, nausea, drainage, dyspnea, beading, syncope, dizziness, anxiety, deeper wrinkle, and granuloma.In many cases, the symptoms resolved without any treatment.Reported treatments have included: antibiotics, steroids, steroidal creams, hyaluronidase, anti-inflammatories, anti-histamines, needle aspiration and drainage, ultrasound therapy, analgesics, anti-viral, excision, eye drops, hyperbaric oxygen, laser resurfacing, tissue debridement, surgical scar revision, ice, massage, and warm compress.Instructions for use if the needle is blocked, do not increase the pressure on the plunger rod.Instead, stop the injection and replace the needle.Patients may have mild to moderate injection site responses, which typically resolve in a few days in the nlfs, and within 2 weeks in the lips and perioral area.If the treated area is swollen immediately after the injection, an ice pack can be applied to the site for a short period.

Event Description

Healthcare professional reported during injection in the lips with juvéderm® ultra xc there was ¿really thick product that was hard to push thru the needle¿ and ¿one of the needles were bent¿ when the injector opened the package.The patient experienced ¿bruising.¿ packaged needle was used.

Manufacturer Narrative

Device analysis summary: no defect observed.

Event Description

Healthcare professional reported during injection in the lips with juvéderm® ultra xc there was ¿really thick product that was hard to push thru the needle¿ and ¿one of the needles were bent¿ when the injector opened the package.The patient experienced ¿bruising.¿ packaged needle was used.

• Brand Name: JUVEDERM ULTRA 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
• 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: 6730667
• MDR Text Key: 80669840
• Report Number: 3005113652-2017-00725
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000081
• UDI-Public: (01)30888628000081(10)H24LA60145(11)160401(17)170901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

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: 09/01/2017
• Device Catalogue Number: 94154
• Device Lot Number: H24LA60145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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: 49 YR