MAUDE Adverse Event Report: ORMCO CORPORATION SPARK ADVANCED

Lot Number 172325

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

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

It was alleged that a patient had an allergic reaction to spark advanced.After discontinuing wearing spark advanced aligner the allergic reaction began to improve within 1-2 days.

Event Description

Patient had an allergic reaction to spark advanced.

Manufacturer Narrative

Follow up on the alleged allergic reaction to spark advanced aligners.Patient took benadryl for the allergic reaction.Patient has recovered after discontinuing the use of spark advanced aligners.

• Brand Name: SPARK ADVANCED
• Type of Device: SPARK ADVANCED
• Manufacturer (Section D): ORMCO CORPORATION; 200 s. kramer blvd, buidling e; brea CA 92821
• MDR Report Key: 11280230
• MDR Text Key: 230338803
• Report Number: 2016150-2021-00002
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 172325
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR