MAUDE Adverse Event Report: ORMCO CORPORATION CUNITI WIRE; COPPER NITI WIRE

Catalog Number 205-1903

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

Patient Problem Foreign Body In Patient (2687)

Event Date 10/29/2016

Event Type  Injury  

Manufacturer Narrative

It was alleged that a patient had swallowed a 2cm piece of arch wire.Wire has been replaced and no long term consequences can be foreseen.

Event Description

Patient swallowed 2cm of wire.

• Brand Name: CUNITI WIRE
• Type of Device: COPPER NITI WIRE
• 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: 6142518
• MDR Text Key: 61398630
• Report Number: 2016150-2016-00006
• Device Sequence Number: 1
• Product Code: DZC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 205-1903
• Device Lot Number: 16A8A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/02/2016
• 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: 15 YR