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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN; ALIGNER, SEQUENTIAL
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ALIGN TECHNOLOGY, INC. INVISALIGN; ALIGNER, SEQUENTIAL Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Pain (1994); Vomiting (2144); Anxiety (2328); Sleep Dysfunction (2517); Weight Changes (2607); Alteration in Body Temperature (4568)
Event Date 06/01/2021
Event Type  Injury  
Event Description
Patient called to report an adverse reaction to her invisalign device.Patient stated since wearing the invisalign, she's been hospitalized 5 times, had trouble breathing, neck pain, vomiting, severe panic attacks that are constant, sweating, body heat rising, insomnia, mind racing, lost 10 pounds in less than two weeks and cannot keep food down.Patient believes her body is reacting to a foreign substance that the invisalign contains.Patient said she took the invisalign out for a few days and her symptoms were slightly improved and she was able to keep food down.Patient stated when she put the invisalign back in, all her symptoms came back.Patient stated she is concerned how long it will take her body to stop reacting and experiencing all of the symptoms.
 
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Brand Name
INVISALIGN
Type of Device
ALIGNER, SEQUENTIAL
Manufacturer (Section D)
ALIGN TECHNOLOGY, INC.
MDR Report Key12040593
MDR Text Key257807255
Report NumberMW5102011
Device Sequence Number1
Product Code NXC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age41 YR
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