MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94506JR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Skin Discoloration (2074); Vertigo (2134)

Event Date 03/12/2017

Event Type  Injury  

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 events of "abscess on the lip area¿, ¿micro abscess and skin rash on the skin, and hand-feet¿, ¿abscess under skin on clavicular¿, ¿color change¿, and ¿vertigo" 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: undesirable effects "the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed.These include, but are not limited to: ¿ inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection.These reactions may last for a week.¿ staining or discolouration of the injection site might be observed, especially when ha dermal filler is injected too superficially and/or in thin skin (tyndall effect).¿patients should receive prompt medical attention and possibly evaluation by an appropriate medical practitioner specialist should an intravascular injection occur.Abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have also been reported.It is therefore advisable to take these potential risks into account.¿ patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops, to their medical practitioner as soon as possible.The medical practitioner should use an appropriate treatment.".

Event Description

Healthcare professional reported patient was injected in "glabella line, precoupe ulkus, and lip" with 1ml of juvéderm® volift¿ with lidocaine and in the cheek with 1ml of unspecified juvederm® voluma¿.Three weeks later patient had touch up with unspecified dermal filler at all the same sites as initial injection.Ten days after injection abscess on the lip area is observed, 7 days later abscess drainage and cipro 500 is used as treatment.Additionally, reported treatment of betaserc due to vertigo.On the "12th days", micro abscess and skin rash are observed on the skin, and hand-feet." after 19 days, abscess under skin on clavicular is observed, color change after injection to glabella line is observed.Hyaluronidase is treated.Local treatment is started with nitroglycerin with cortisol and topical antibiotic pomade.Healing is observed on glabella line.Betaserc, levation and cipro is prescribed as treatment.This is the same event and the same patient reported under mdr id# 3005113652-2017-00255 ((b)(4)) and mdr id# 3005113652-2017-00256 ((b)(4)).This is the third mdr submitted for the third suspect product, unspecified juvederm® voluma¿, also a device manufactured by allergan.

Event Description

Additional information: prior to injection patient was pretreated with a topical antiseptic and after injection patient used ice.

Manufacturer Narrative

(b)(4).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 patient was injected in "glabella line, precoupe ulkus, and lip" with 1ml of juvéderm® volift¿ with lidocaine and in the cheek with 1ml of unspecified juvederm® voluma¿.Three weeks later patient had touch up with unspecified dermal filler at all the same sites as initial injection.Ten days after injection abscess on the lip area is observed, 7 days later abscess drainage and cipro 500 is used as treatment.Additionally, reported treatment of betaserc due to vertigo.On the "12th days", micro abscess and skin rash are observed on the skin, and hand-feet." after 19 days, abscess under skin on clavicular is observed, color change after injection to glabella line is observed.Hyaluronidase is treated.Local treatment is started with nitroglycerin with cortisol and topical antibiotic pomade.Healing is observed on glabella line.Betaserc, levation and cipro is prescribed as treatment.This is the same event and the same patient reported under mdr id# 3005113652-2017-00255 ((b)(4)) and mdr id# 3005113652-2017-00256 ((b)(4)).This is the third mdr submitted for the third suspect product, unspecified juvederm® voluma¿, also a device manufactured by allergan.Additional information: prior to injection patient was pretreated with a topical antiseptic and after injection patient used ice.

• Brand Name: JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1
• 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: 6511444
• MDR Text Key: 73376984
• Report Number: 3005113652-2017-00262
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P110033
• 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,Followup,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 94506JR
• Device Lot Number: VB20A60271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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): Required Intervention