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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

A doctor alleged that a patient had experienced an infection of the gingiva while wearing a herbst appliance.

Manufacturer Narrative

The doctor reported that the infection was caused by food which had been caught underneath the crown of the appliance.The doctor removed the appliance and prescribed a chlorhexidine rinse for treatment.To date, the patient has fully recovered and is doing fine.A new appliance will be made 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: 4167080
• MDR Text Key: 4868394
• Report Number: 2184045-2014-00005
• 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: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Other Device ID Number: WO #7692655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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