MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for INVISALIGN CLEAR ALIGNERS AND INVISALIGN 'ALTERNATIVE MANUFACTURING PROCESS,CLEA manufactured by Align Technology Inc..
[177401643]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092661 |
| MDR Report Key | 9653679 |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-11-20 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN CLEAR ALIGNERS AND INVISALIGN 'ALTERNATIVE MANUFACTURING PROCESS,CLEA |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-01-30 |
| Returned To Mfg | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIGN TECHNOLOGY INC. |
| Manufacturer Address | SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-30 |