ESSEX RETAINER (C+)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-07 for ESSEX RETAINER (C+) manufactured by Dentsply Raintree Essix Metairie.

Event Text Entries

[82371038] Received essex c+ retainer from my orthodontist. Within 72 hours of wear, i experienced a burning tongue, lips and slight swelling. When removed, the burning tongue and lips stopped within 45 minutes to an hour. I left the retainer out for 24 hours and then retried the appliance and within 2-5 minutes of inserting the retainer, i experienced the same burning of tongue and lips which then resolved in 45 min to 1 hr after removal. I have reported this to my orthodontist. Important info: lower braces were removed prematurely (only had them on 2 months) on (b)(6) 2017 due to burning/tingling tongue/lower lip with some swelling with thick while coating to tongue. Orthodontist suspected possible allergy to a metal alloy (possibly nickel). Oral candida was ruled out by my gp and my orthodontist also indicated that my tongue swelling, tenderness, burning/pain was not due to oral candida based on her clinical observation. In less than 24 hr of removal of all metal hardware, my tongue and lips completely stopped burning and my mouth returned to normal. On monday (b)(6) i received my essix retainer and within 72 hours of wearing it, i started experiencing the very same reactions - slightly swollen tongue, lips, burning/tingling pain.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071450
• MDR Report Key: 6776751
• Date Received: 2017-08-07
• Date of Report: 2017-08-07
• Date of Event: 2017-08-01
• Date Added to Maude: 2017-08-09
• 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: PATIENT
• 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: 0

Device Details

• Brand Name: ESSEX RETAINER (C+)
• Generic Name: TOOTH POSITIONER
• Product Code: DYJ
• Date Received: 2017-08-07
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DENTSPLY RAINTREE ESSIX METAIRIE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-08-07