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 developed sores on the upper and lower right cheek while wearing a herbst appliance.

Manufacturer Narrative

Patient specifics with regard to age and weight were not provided.The doctor removed the appliance and prescribed antibiotics for treatment.To date, the patient has fully recovered and is doing fine.A new appliance will be fabricated with consideration to the patient comfort.An evaluation of the returned device is anticipated, but has not yet begun.

Manufacturer Narrative

The returned appliance was evaluated against a new model of the patient's mouth and it was confirmed that the appliance does not fit.It was discovered that the lower jaw cantilevers and the upper jaw extended tube on the right side had protruded too far buccally.A new appliance will be fabricated with regard 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 w collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 3919834
• MDR Text Key: 4665686
• Report Number: 2184045-2014-00002
• 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,Followup
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Other Device ID Number: WO #7667774
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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