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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALIGN TECHNOLOGY INC. INVISALIGN CLEAR ALIGNERS AND INVISALIGN 'ALTERNATIVE MANUFACTURING PROCESS,CLEA; ALIGNER, SEQUENTIAL

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ALIGN TECHNOLOGY INC. INVISALIGN CLEAR ALIGNERS AND INVISALIGN 'ALTERNATIVE MANUFACTURING PROCESS,CLEA; ALIGNER, SEQUENTIAL Back to Search Results
Device Problem Product Quality Problem (1506)
Patient Problems Burning Sensation (2146); Patient Problem/Medical Problem (2688)
Event Date 11/20/2019
Event Type  Injury  
Event Description
Pt undergoing treatment with invisalign aligners.Experienced burning sensation on her tongue and metallic taste in her mouth after initial aligner delivery.Invisalign replaced aligners with 'alternate mfg process' and symptoms continued.She discontinued aligner wear, and symptoms persisted for several weeks, including significant alteration of taste sensation.After abatement of symptoms, she transitioned to 3m clarity aligners, and has been asymptomatic since.She was treated by an oral medicine specialist, and was treated with a steroid and an anti-fungal medication.Fda safety report id# (b)(4).
 
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Brand Name
INVISALIGN CLEAR ALIGNERS AND INVISALIGN 'ALTERNATIVE MANUFACTURING PROCESS,CLEA
Type of Device
ALIGNER, SEQUENTIAL
Manufacturer (Section D)
ALIGN TECHNOLOGY INC.
san jose CA
MDR Report Key9653679
MDR Text Key177401643
Report NumberMW5092661
Device Sequence Number1
Product Code NXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Dentist
Type of Report Initial
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2019
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age63 YR
Patient Weight66
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