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

Catalog Number 94154EC

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Improper or Incorrect Procedure or Method (2017)

Patient Problems Edema (1820); Hyperemia (1904)

Event Date 12/30/2015

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 05/05/2016.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events of edema and hyperemia are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device history record summary: the documentary research in the batch file shows that no element could explain these reactions: all the manufacturing steps and all the physicochemical and microbiological results (endotoxins, bioburden) are registered as conforming to the specifications.The sterilization cycle is registered as conforming.Device labeling addresses the reported events of boxes opened and wrinkled, internal packing opened, internal seal loose, insert kneaded, edema, and hyperemia as follows: "do not use if the packaging is damaged." undesirable effects "the patient must be informed that there are potential side effects linked to this procedure, which can be either immediate or delayed.These include, but are not limited to: inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching or pain on pressure or both, occurring after the injection.".

Event Description

Healthcare professional reported receiving 10 boxes of juvéderm ultra xc in ¿bad conditions, some boxes were opened and also the internal packing was opened.¿ additionally, the boxes were wrinkled and the insert was ¿completely kneaded¿ but the ¿external packaging (where the products were received) was intact.¿ upon the physician opening the internal package they noticed the ¿seal was loose¿ and ¿by that time [they] had another package to open so the product was applied.¿ the healthcare professional injected a patient to the ¿marginalis arches osseointegration¿ with 2 syringes from one of these boxes of juvéderm ultra xc.A couple of minutes after injection there was ¿immediate reaction with edema and local hyperemia, evolution worsening¿ at the injection site and extending to the surrounding areas.Patient was prescribed antibiotics, corticosteroid, and diuretics.Patient was ¿still unsatisfied¿ so it ¿was necessary to use hyaluronidase¿ on several occasions.Symptoms are ongoing.

• 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
• 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: 5633627
• MDR Text Key: 44469860
• Report Number: 3005113652-2016-00179
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 94154EC
• Device Lot Number: H24LA50294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• 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 Age: 48 YR