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

Catalog Number UNK JUVEDERM-CONC/ADD

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

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Manufacturer Narrative

Allergan is unable to confirm with the patient or healthcare professional; therefore, additional event, product, or patient details are not attainable.The event 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.This is a known potential adverse event addressed in the product labeling.

Event Description

Social media report states that "someone i know had a stroke as result of fillers" and "there are variety of fillers in the market from low quality to premium quality and juvéderm®".No additional details available.

• 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: 10295423
• MDR Text Key: 199481968
• Report Number: 3005113652-2020-00390
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P050047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK JUVEDERM-CONC/ADD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2020
• 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: N
• Patient Sequence Number: 1