MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94640

Device Problems Migration or Expulsion of Device (1395); Material Too Rigid or Stiff (1544); Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

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 "movement of the product to the superficial dermis," "extrusion and intermediate rejection," nodule, "product is coming out in spurts," and "permanent impairment" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Device labeling addresses the reported event(s) as follows: "precautions: ¿ patients may experience late onset nodules with use of dermal fillers, including juvéderm voluma® xc.Adverse events: per table 1: treatment site responses by maximum severity occurring in > 5% of subjects after initial treatment (n = 265) possible treatment site responses post injection with juvéderm voluma® xc include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.Treatment site responses reported by [less than or equal to] 5% of subjects included ache, acne, bulge, bumps, cheek larger upon waking up, dry patch, fine wrinkles, injection/needle marks, numbness, pigmentation from treatment, puffiness, rash, scratch near injection point, soreness, tightness, and yellowness.Device- and injection related adverse events occurring in [less than or equal to] 1% of subjects included injection site hypertrophy (0.7%), nodule (0.7%), inflammation (0.4%), injection site anesthesia (0.4%), injection site dryness (0.4%), injection site erosion (0.4%), mass (0.4%), contusion (0.4%) and syncope (0.4%).Post-market surveillance: juvéderm voluma® without lidocaine has been marketed outside the us since 2005, and juvéderm voluma® with lidocaine has been marketed outside the us since 2009.As of december 31, 2012, the following aes were received from post-market surveillance for juvéderm voluma® with and without lidocaine with a frequency [greater than or equal to] 5 and were not observed in the clinical study; this includes reports received globally from all sources including scientific journals and voluntary reports.All aes obtained through post-market surveillance are listed in order of number of reports received: inflammatory reaction, lack of correction, infection, migration, granuloma, allergic reaction, abscess, necrosis, numbness, and vision abnormalities.Reported treatments include: antibiotics, steroids, hyaluronidase, anti-inflammatories, anti-histamines, aspiration, radio frequency therapy, laser treatment, ice, massage, warm compress, analgesics, anti-viral, ultrasound, excision, drainage, and surgery.".

Event Description

Healthcare professional reported that six months after injection on the bone along the zygomatic arch with juvéderm voluma® xc the patient experienced "movement of the product to the superficial dermis" and "extrusion and intermediate rejection in which there is a nodule at the skin and product is coming out in spurts." the product is hard upon removal.A ct scan was administered that showed "product extending from the bone up to the skin." the patient has not been treated.The "event has led to permanent impairment.".

Manufacturer Narrative

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 extrusion force value shows an expected consistency of the product.The sterilization cycle is registered as conforming.

Event Description

Healthcare professional reported that six months after injection on the bone along the zygomatic arch with juvéderm voluma® xc the patient experienced "movement of the product to the superficial dermis" and "extrusion and intermediate rejection in which there is a nodule at the skin and product is coming out in spurts." the product is hard upon removal.A ct scan was administered that showed "product extending from the bone up to the skin." the patient has not been treated.The "event has led to permanent impairment.".

• Brand Name: JUVEDERM VOLUMA XC 27G 2 X 1ML
• 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: 6292565
• MDR Text Key: 66242941
• Report Number: 3005113652-2017-00017
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 30888628000012
• UDI-Public: (01)30888628000012(10)VB20A50090(11)150226(17)160726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110033
• 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: 03/09/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2016
• Device Catalogue Number: 94640
• Device Lot Number: VB20A50090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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 Outcome(s): Disability