MAUDE Adverse Event Report: AOA MARA; MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE

Lot Number 4693229

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/07/2019

Event Type  Injury  

Event Description

Doctor alleged the patient swallowed a mara elbow and shim.

• Brand Name: MARA
• Type of Device: MANDIBULAR ANTERIOR REPOSITIONING APPLIANCE
• Manufacturer (Section D): AOA; 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: 8941269
• MDR Text Key: 155946774
• Report Number: 2184045-2019-00003
• 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: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 4693229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2019
• Is the Device Single Use?: Yes
• 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: 9 YR