MAUDE Adverse Event Report: ORTHO ORGANIZERS, INC CARRIERE MOTION 3D COLORS CLASS II 27MM RIGHT - SILVER; METAL ORTHODONTIC BRACKET

Model Number 424-927RN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ulcer (2274); Pressure Sores (2326)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

Dentist prescribed debactrol for "canker sores" on (b)(6).It is expected that the prescribed medication will resolve the irritation.

Event Description

Patient had device bonded on (b)(6) 2018.On (b)(6), patient presented to dental office with canker sores.Device was debonded, and debacterol treatment was initiated by dentist on (b)(6) 2018.

• Brand Name: CARRIERE MOTION 3D COLORS CLASS II 27MM RIGHT - SILVER
• Type of Device: METAL ORTHODONTIC BRACKET
• Manufacturer (Section D): ORTHO ORGANIZERS, INC; 1822 aston avenue; carlsbad CA 92008 7306
• Manufacturer (Section G): ORTHO ORGANIZERS, INC; 1822 aston avenue; carlsbad CA 92008 7306
• Manufacturer Contact: mary pearman ; 1822 aston avenue; carlsbad, CA 92008
• MDR Report Key: 8124525
• MDR Text Key: 129042539
• Report Number: 2081322-2018-00002
• Device Sequence Number: 1
• Product Code: EJF
• UDI-Device Identifier: 00190707023447
• UDI-Public: 00190707023447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510(K) EXEMP
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 424-927RN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 48 YR
• Patient Weight: 54