MAUDE Adverse Event Report: SDS DE MEXICO S. DE R.L. DE C.V. CUNITI WIRE; DAMON COPPER NITI WIRE

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

It was alleged that the copper niti wire fractured at the distal end of fron molar while the patient was eating and patient swallowed the 15-17mm wire.This wire was immediately removed.To date the patient has fully recovered.

Event Description

Patient swallowed 15-17mm wire.

Event Description

Patient swallowed 15-17mm wire.

• Brand Name: CUNITI WIRE
• Type of Device: DAMON COPPER NITI WIRE
• Manufacturer (Section D): SDS DE MEXICO S. DE R.L. DE C.V.; circuito sur no. 31; mexicali, mexico C.P. 2139; MX C.P. 21395
• Manufacturer (Section G): SDS DE MEXICO S. DE R.L. DE C.V.; circuito sur no. 31; mexicali, mexico C.P. 2139; MX C.P. 21395
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill ave.; glendora, CA 91740 ; 9099625730
• MDR Report Key: 7346747
• MDR Text Key: 102715255
• Report Number: 2016150-2018-00011
• 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: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR