MAUDE Adverse Event Report: ORMCO CORPORATION INSPIRE ICE; ORTHODONTIC BRACKET

Catalog Number 746-4300

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

A doctor's office alleged that eight (8) patients had experienced mucosa damage after wearing the inspire ice bracket.This is the eighth of eight (8) reports.

Manufacturer Narrative

Specific patient information with regard to gender, age and weight was not provided.The patient was prescribed pain medication and medication for the mucosa.To date, the patient has fully recovered and is doing fine.The device involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.

• Brand Name: INSPIRE ICE
• Type of Device: ORTHODONTIC BRACKET
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hills avenue; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer Contact: kerri casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 4600781
• MDR Text Key: 21553759
• Report Number: 2016150-2015-00011
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 746-4300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention