MAUDE Adverse Event Report: ORMCO CORPORATION DAMON COPPER NITI WIRE; WIRE, ORTHODONTIC

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

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

It was alleged that a patient swallowed a wire and surgical intervention may have been required; however no further specific information has been received at this time.An update will be provided upon receipt of new information.

Event Description

It was alleged that a patient swallowed damon cuniti wire.

Manufacturer Narrative

• Brand Name: DAMON COPPER NITI WIRE
• Type of Device: WIRE, ORTHODONTIC
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill ave.; glendora, CA 91740 ; 9099625730
• MDR Report Key: 5184184
• MDR Text Key: 29727086
• Report Number: 2016150-2015-00021
• Device Sequence Number: 1
• Product Code: DZC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/08/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other