MAUDE Adverse Event Report: ALLESEE ORTHODONTIC APPLIANCES HERBST

Catalog Number	3000-0010
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor alleged the left herbst mechanism and two screws came loose ant the patient swallowed the components.The patient visited the hospital and x-rays were taken of the chest and abdomen.Results of the x-rays indicate no blockage.Patient monitoring for components to pass naturally.

• Brand Name: HERBST
• Common Device Name: HERBST
• 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: suzanne simpkins ; 13931 spring street; sturtevant, WI 53177 ; 2628861050
• MDR Report Key: 19143437
• Report Number: 2184045-2024-00001
• Device Sequence Number: 20823301
• Product Code: DYJ
• UDI-Device Identifier: 00889989038439
• UDI-Public: 00889989038439
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3000-0010
• Device Lot Number: 32650387
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 17 YR
• Patient Sex: Female