MAUDE Adverse Event Report: ALLERGAN (PRINGY) UNK VOLBELLA; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK VOLBELLA

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported patient was injected in the face with juvéderm® voluma¿ with lidocaine and in the dark circles with juvéderm® volbella¿ with lidocaine.After the covid vaccination, patient presented bulging eyelid, eye area on one side, that was managed with application of hyaluronidase and prednisolone for two days and radiofrequency in the area to resolve it.This was repeated 3 more times and symptoms resolved.Six months later, patient was injected in the face with 3 cc of juvéderm® voluma¿ with lidocaine.About two hours and a half later, patient reported bruising in left cheek and nasal area and was asked to go immediately to the office.Patient presented ¿a complication [they] defined as thrombus in the face in the right hemiface and nasal congestive area.That same day, patient was treated with sildenafil, prednisone, aspirin, and pentoxifylline.About two hours later, patient had hyaluronidase diluted in saline solution and/or plain xylocaine injected into the affected area.Traumeel, graphites homaccord, embryo totalis, cutis compositium, coenzyme compositium, lymphomyosot, placenta compositium, engystol, and vitamin c were applied to the affected area.Patient had a second application of hyaluronidase diluted in saline solution.The next day, patient was treated at hyperbaric chamber.Then, patient was treated with sildenafil, prednisone, aspirin, pentoxifylline, and clenoz.Another hyaluronidase diluted with simple xyolicaine / saline solution was injected to the affected area then "heel medications¿ were applied to the area.Another round of radiofrequency application in the area was performed.Hyaluronidase diluted in saline solution was injected again then plasma applied to affected area.Patient was then given sildenafil, aspirin, pentoxifylline, and clenox.Patient continued with hyperbaric chamber (for five days), application of heel products in the area (for 8 days), plasma application (8 days) and start antibiotic treatment with cefreadoxil for one week.The event is ongoing.This is the same event and the same patient reported under mdr id# 3005113652-2022-00675 (allergan complaint #(b)(4)), mdr id# 3005113652-2022-00689 (allergan complaint #(b)(4)).This mdr is being submitted for the suspect product, juvéderm® volbella¿ with lidocaine.

Event Description

Additionally, patient was injected with 1 cc into ck3, prejolws, temporal angle mouth and superior nasogenian angle.Event resolved approximately six months after date of onset.

• Brand Name: UNK VOLBELLA
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15644484
• MDR Text Key: 302166168
• Report Number: 3005113652-2022-00690
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK VOLBELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Hispanic