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

Model Number AW6016 REV K

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Fatigue (1849); Fever (1858); Swelling (2091); Vomiting (2144); Dizziness (2194)

Event Date 07/17/2019

Event Type  Injury  

Event Description

After about four hours i began to experience severe nausea, extreme dizziness.I removed the product (for vomit and clean) and after 4/5 hrs i started feeling better.Not having associated the problem to the device, i wore it again and after 4 hrs the same symptoms recurred and in addition: vomiting, swelling of the tongue, diarrhea, fever resolved with 60mg of deflazacort for two days.With consequent strong asthenia, lack of appetite.The symptoms subsided 24 hrs after the product was removed.Fda safety report id# (b)(4).

• Brand Name: INVISALIGN FULL
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.
• MDR Report Key: 8821898
• MDR Text Key: 152105312
• Report Number: MW5088308
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00816063020233
• UDI-Public: (01)00816063020233
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AW6016 REV K
• Device Catalogue Number: 9005
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: C-VITAMIN SUPPLEMENT; GABA SUPPLEMENT; OMEGA3 SUPPLEMENT
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 87