MAUDE Adverse Event Report: ALLESEE ORTHODONTIC APPLIANCES HERBST; BITE-JUMPING ORTHODONTIC APPLIANCE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced sores on their cheek while wearing a herbst appliance.

Manufacturer Narrative

Specific patient information such as gender, age, and weight was not provided.The patient had developed a sore on the lower right lip mucosa due to the lower axle/miniscope mechanism rubbing.The doctor removed the appliance and prescribed peroxyl and orabase for treatment.To date, the patient has fully recovered and is doing fine.A new appliance will be fabricated with consideration to patient comfort.

• Brand Name: HERBST
• Type of Device: BITE-JUMPING ORTHODONTIC APPLIANCE
• Manufacturer (Section D): ALLESEE ORTHODONTIC APPLIANCES; 13931 spring street; sturtevant WI 53177
• Manufacturer (Section G): ALLESEE ORTHODONTIC APPLIANCES; 13931 spring street; sturtevant WI 53177
• Manufacturer Contact: kerri casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 4439016
• MDR Text Key: 5387948
• Report Number: 2184045-2015-00002
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Other Device ID Number: WO #7744977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention