MAUDE Adverse Event Report: ORMCO CORPORATION INC. ADVANSYNC CROWNS

Device Problem Insufficient Information (3190)

Patient Problem Nipple Ulceration (2441)

Event Type  Injury  

Manufacturer Narrative

A doctor alleged that the appliance cut into the cheeks of the patient and created an ulceration.The doctor cleaned the wound and did a laser treatment and added ointment.To date, the patient is doing fine.

Event Description

A doctor alleged that a patient's advansync appliance caused by cutting into the cheeks of the patient and created an ulceration.

Manufacturer Narrative

• Brand Name: ADVANSYNC CROWNS
• Type of Device: ADVANSYNC CROWNS
• Manufacturer (Section D): ORMCO CORPORATION INC.; 1332 south lone hill ave.; glendora CA 91740
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill ave.; glendora, CA 91740 ; 9099625730
• MDR Report Key: 5218216
• MDR Text Key: 30988868
• Report Number: 2016150-2015-00022
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other