MAUDE Adverse Event Report: ALLERGAN (IRVINE) BELKYRA SKIN GRID; MARKER, SKIN

Catalog Number BELKYRA SKIN GRID

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

Patient Problems Abscess (1690); Necrosis (1971)

Event Date 02/04/2022

Event Type  Injury  

Event Description

Healthcare professional reported injecting a patient in the sub-cutaneous into pre-platysmal fat within safe borders with 2 vials belkyra¿.The belkyra¿ skin grid was used.Post-procedure ¿oedema¿ was present.Six days later, ¿small pustules¿ began forming within the treated area followed by ¿ulceration and skin breakdown/necrosis¿ within the following days.The patient was on keflex oral tablets and chlorsig ointment.The patient reports pain and itching at site of wound.The event status is unknown.

Manufacturer Narrative

Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The events 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.

• Brand Name: BELKYRA SKIN GRID
• Type of Device: MARKER, SKIN
• Manufacturer (Section D): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• Manufacturer (Section G): ALLERGAN (IRVINE); 2525 dupont drive; irvine CA 92612
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14350287
• MDR Text Key: 291347272
• Report Number: 2024601-2022-00001
• Device Sequence Number: 1
• Product Code: FZZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BELKYRA SKIN GRID
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male