MAUDE Adverse Event Report: ALIGN TECHNOLOGY INVISALIGN; MANITAINER, SPACE PERFORMED, ORTHODONTIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Red Eye(s) (2038); Swelling (2091); Burning Sensation (2146); Blood Loss (2597)

Event Date 07/01/2017

Event Type  Injury  

Event Description

Started invisalign dental correction in (b)(6) 2017 and developed side effects of burning tongue, swollen face, bloody nose, red eyes and extreme fatigue.Got worse the longer i wore the retainers.Took a four week break and within a week all symptoms were gone.Initiated treatment again wearing the retainer in a "hypoallergenic" formula and symptoms were back immediately.Align technology is the manufacturing company.

• Brand Name: INVISALIGN
• Type of Device: MANITAINER, SPACE PERFORMED, ORTHODONTIC
• Manufacturer (Section D): ALIGN TECHNOLOGY
• MDR Report Key: 6950936
• MDR Text Key: 89560887
• Report Number: MW5072754
• Device Sequence Number: 1
• Product Code: DYT
• Combination Product (y/n): N
• 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: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 62