INVISALIGN BRACES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-02 for INVISALIGN BRACES manufactured by .

Event Text Entries

[827818] In 2007- dentist gave me fresh cleanse to clean invisalign. Used it according to instructions. During that month, got eye infections, frequent urination, left eye drooping, ringing in ears. Didn't connect it to braces/denture cleanser. In early 2008, dentist gave me new invisalign uppers and polident tablets. Next day had chest pain, heart surgery (but had a cold, so didn't connect ot invisalign/cleanser). Over next few weeks to the following month several er and doctor visits, had chest pain, face numb, tingling feet and hands, heart palpitations, fever and chills, felt like burning inside me, severe acid/gastro reflux, dizzy and lightheaded, pain in neck/jaw/back/face, nausea, sore throat, high bp, tremors. Stopped using both products the same day. Some symptoms have subsided, but still have chest pain, urinary pain, tremors, racing heart, acid reflux. Products were all used according to instructions. Dates of use: 2007 to 2008. Event abated after use stopped or dose reduced? Yes, still serious health issues after one month.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5006098
• MDR Report Key: 1024997
• Date Received: 2008-04-02
• Date of Report: 2008-03-27
• Date of Event: 2007-12-01
• Date Added to Maude: 2008-04-14
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: INVISALIGN BRACES
• Generic Name: *
• Product Code: KMY
• Date Received: 2008-04-02
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 992953

Device Sequence Number: 2

• Brand Name: POLIDENT
• Generic Name: NONE
• Product Code: EFT
• Date Received: 2008-04-02
• Operator: HEALTH PROFESSIONAL
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 2
• Device Event Key: 992954

Device Sequence Number: 3

• Brand Name: FRESH CLEANSE DENTURE CLEANSER
• Generic Name: NONE
• Product Code: EFT
• Date Received: 2008-04-02
• Operator: HEALTH PROFESSIONAL
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 3
• Device Event Key: 992955

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-04-02