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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Specific patient information such as weight was not provided.The patient experienced that the herbst device had encroached upon the soft tissues and caused oral lesions on the patients cheeks.The doctor removed appliance and recommended that the patient rinse with chlorhexidine.To date the patient is doing fine; however, scar tissue is now present.

Event Description

Doctor alleged that patient experienced severe trauma to the cheeks.

• Brand Name: HERBST
• Type of Device: BITE-JUMPING ORTHODONTIC APPLIANCE
• Manufacturer (Section D): HERBST; allesee orthodontic appliances; 13931 spring street; sturtevant WI 53177
• Manufacturer Contact: mary lambert ; 13931 spring street; sturtevant, WI 53177 ; 2623213670
• MDR Report Key: 5624655
• MDR Text Key: 44278764
• Report Number: 2184045-2016-00001
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• 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
• Patient Age: 12 YR