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U.S. Department of Health and Human Services

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

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ALLERGAN (PRINGY) JUVEDERM VOLUMA XC 27G 2 X 1ML IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94640
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Scarring (2061); Skin Inflammation (2443)
Event Date 06/15/2016
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 "pustules," "pustular acne," scarring, and "lasting depression" 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: 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 addresses the reported event(s) as follows: "warnings: ¿ treatment site reactions consist mainly of short-term inflammatory symptoms and generally resolve within 2 to 4 weeks. 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 approximately 2 months after injection in the cheeks with 1 syringe of juvéderm voluma® xc the patient developed pustules in the injection area after experiencing pustular acne. The pustule was drained, patient was treated with oral antibiotics, and filler was removed by hyaluronidase. The hyaluronidase was injected approximately 4 months, 6. 5 months, and 7 months after the initial injection. Symptoms resolved "except scarring due to" the filler. The patient has a lasting depression from the abscess and "will be seeing a plastic surgeon for possible fat transplant. ".
 
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Brand NameJUVEDERM VOLUMA XC 27G 2 X 1ML
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 Key6271466
MDR Text Key65542431
Report Number3005113652-2017-00006
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2017
Device Catalogue Number94640
Device Lot NumberVB20A50436
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2015
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: 01/23/2017 Patient Sequence Number: 1
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