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); Unspecified Infection (1930); Inflammation (1932)

Event Type  Injury  

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 of inflamed lymph nodes, abscess and infection are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.

Event Description

Patient reported having been injected with belkyra.It is not known if the skin grid was used.Patient developed inflamed lymph nodes in the right lateral submandibular area 2 weeks after the injection.Patient then developed an abscess afterwards.It was noted that the infection was treated with antibiotics and drainage.Symptoms ongoing.

• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8254055
• MDR Text Key: 133256335
• Report Number: 2024601-2019-00002
• Device Sequence Number: 1
• Product Code: FZZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• 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
• Date Manufacturer Received: 12/20/2018
• 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
• Treatment: BELKYRA
• Patient Outcome(s): Required Intervention