MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN; ALIGNER, SEQUENTIAL

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943)

Event Date 07/02/2021

Event Type  Injury  

Event Description

Invisalign- caused systemic allergic reaction.Whole body turned red, itching, arms, hands, legs, feet swelling.Had to go to er.Administered iv fluids with benadryl and steroids and h2 blockers.Event re-occurred when second tray used/same reaction.Orthodontist had trays remade with extra/special washing procedures which corrected the issue.Almost went into shock.Fda safety report id # (b)(4).

• Brand Name: INVISALIGN
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 12342912
• MDR Text Key: 267626947
• Report Number: MW5103348
• Device Sequence Number: 1
• Product Code: NXC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 65