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

Catalog Number	UNK HARMONYCA LIDO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continued d.10.Concomitant therapies: amlodipine, furoate, mometasone, citalopram, betaderm, and irbesartan.Continued h.6.Health effect - impact codes: f2303 clarification to h.6.Type of investigation code: the filler was injected into the patient and is not accessible for return.The syringe was not returned for evaluation.The event is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.The event of hernia, deemed not device related is considered an unexpected adverse drug experience.
Event or Problem Description
Healthcare professional (hcp) reported a clinical patient was injected in the cheeks bilaterally with 2.3ml of harmonyca lidocaine.About one month later the patient received touch-up injections with 1.1ml of harmonyca lidocaine.The patient was concomitantly treated with topical pre-treatment anesthesia and concomitantly takes amlodipine, furoate, mometasone, citalopram, betaderm, and irbesartan.Approximately seven months and a half after the touch-up injections the patient experienced non device related ¿hernia¿.About three weeks later, patient was hospitalized and underwent a hernia surgery.Patient was also treated with hydromorphone.The event resolved the same day.This is the same event and the same patient reported under mdr id# 3005113652-2024-0011046 (abbvie complaint # (b)(4).This mdr is being submitted for the first injection.

• Brand Name: UNK HARMONYCA LIDOCAINE
• Common Device Name: 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 ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 19409878
• Report Number: 3005113652-2024-001104
• Device Sequence Number: 8278005
• Product Code: LMH
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: -
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: UNK HARMONYCA LIDO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TOPICAL PRE-TREATMENT ANESTHESIA
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White