MAUDE Adverse Event Report: ORMCO CORPORATION MINI DIAMOND TWIN

Catalog Number 321-1251

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

It was alleged that a patient had an allergic reaction; no medical prescriptions required.It was confirmed no serious injury was associated with this incident.To date the patient is doing fine.

Event Description

It was alleged a patient had a diffused ulcer on her mouth and was unable to eat.Doctor suspected that the patient was allergic to the metal of the brackets.

• Brand Name: MINI DIAMOND TWIN
• Type of Device: MINI DIAMOND TWIN
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill ave.; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 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: 6756438
• MDR Text Key: 81484007
• Report Number: 2016150-2017-00003
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 321-1251
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR