MAUDE Adverse Event Report: DYNAFLEX MILLED ADJUSTABLE HERBST

Model Number 56GM

Device Problem Biocompatibility (2886)

Patient Problems Local Reaction (2035); Localized Skin Lesion (4542); Contact Dermatitis (4546)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

No conclusive evidence has been provided that supports or opposes the fact that the herbst appliance caused or contributed to the patient's symptoms.This event is being filed as an mdr as the patient reported an allergic reaction while a dynaflex product was being used.

Event Description

Within about 2 weeks of using the dental sleep appliance, patient developed lesions on tongue, roof of mouth and cheeks.Symptoms resolved after patient discontinue use.Appears to be previously undiagnosed acrylic allergy.Patient sought care of a doctor who prescribed a yeast cream which had no effect.Believe this to be a previously undiagnosed acrylic allergy.

• Brand Name: MILLED ADJUSTABLE HERBST
• Type of Device: ADJUSTABLE HERBST
• Manufacturer (Section D): DYNAFLEX; 8050 hawk ridge trail; lake st louis MO 63367
• MDR Report Key: 12711088
• MDR Text Key: 278780128
• Report Number: 1937100-2021-00001
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• PMA/PMN Number: K103076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 56GM
• Device Catalogue Number: 56GM
• Device Lot Number: R020816
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR