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

Device Problem Insufficient Information (3190)

Patient Problem Ulceration (2116)

Event Type  Injury  

Manufacturer Narrative

Doctor alleged the patient has very tight cheek muscles and experienced an ulceration from the lower applecore screws.Patient to date has recovered.

Event Description

Patient has very tight cheek muscles and experienced an ulceration from the lower applecore screws.

• Brand Name: HERBST
• Type of Device: BITE-JUMPING ORTHODONTIC APPLIANCE
• Manufacturer (Section D): ALLESEE ORTHODONTIC APPLIANCES; 13931 spring street; sturtevant WI 53177
• Manufacturer Contact: mari lambert ; 13931 spring street; sturtevant, WI 53177 ; 2623213670
• MDR Report Key: 5889287
• MDR Text Key: 52558886
• Report Number: 2184045-2016-00003
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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