MAUDE Adverse Event Report: UNKNOWN MANUFACTURER UNK DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK DERMAL FILLER

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

Patient Problems Inflammation (1932); Paralysis (1997)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

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 events of "inflammation irritation" and "neurological symptoms" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported injecting a patient with an unknown dermal filler in the "full face." approximately three months later, patient experienced "inflammation in the intern área of the right eye." the next day the issue worsened and began affecting the half of the left side of the face.The patient was prescribed 600mg ibuprofen for 3 days.The next day, the patient went to the emergency room as the "edema increased, mostly in cheeks and she felt paralysis of right." the patient was diagnosed with "peripheric facial paralisis" and was treated with corticoids.The event is ongoing.

• Brand Name: UNK DERMAL FILLER
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): UNKNOWN MANUFACTURER
• Manufacturer (Section G): UNKNOWN MANUFACTURER
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12464931
• MDR Text Key: 271306578
• Report Number: 3005113652-2021-03204
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P800022
• 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
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK DERMAL FILLER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/13/2021
• 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