MAUDE Adverse Event Report: ALLERGAN (PRINGY) JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK JUVEDERM-CONC/ADD

Device Problem Migration (4003)

Patient Problems Unspecified Infection (1930); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Healthcare professional reports a mid-face lift and moderate postoperative contour deformity. Patient was treated with injection of an unspecified juvéderm® product in the mid face. An unspecified amount of time later, unspecified juvéderm® and juvéderm voluma® xc were injected into the midface. The patient experienced ¿product migration, thinning of the skin, increasing contour deformities at areas adjacent to the injections. ¿ incision and drainage completed at least 7 times as treatment. The symptoms are ongoing. Permanent damage probable and noted as ¿skin discoloration, seromas, lack of attachment of skin to soft tissues. ¿ per healthcare professional, "not only was this deforming psychologically devastating, but [patient] still cannot show face in public. " this is the same event and the same patient reported under mdr id# 3005113652-2020-00464 (allergan complaint #(b)(4)) and mdr id# 3005113652-2020-00466 (allergan complaint #(b)(4)). This mdr is being submitted for the second injection with an unspecified juvéderm® product.

• Brand Name: JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)
• 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10356486
• MDR Text Key: 201377096
• Report Number: 3005113652-2020-00465
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK JUVEDERM-CONC/ADD
• 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 Received: 07/08/2020
• 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

Patient Treatment Data

Date Received: 08/03/2020 Patient Sequence Number: 1

Treatment

JUVÉDERM VOLUMA® XC