MAUDE Adverse Event Report: SDS DE MEXICO DAMON CUNITI ARCHWIRE

Catalog Number 205-1909

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2018

Event Type  Injury  

Event Description

It was alleged that two patients swallowed the archwires.

• Brand Name: DAMON CUNITI ARCHWIRE
• Type of Device: DAMON CUNITI ARCHWIRE
• Manufacturer (Section D): SDS DE MEXICO; s. de r.l. de c.v.; circuito sur no. 31; mexicali, mexico 21395 ; MX 21395
• Manufacturer (Section G): SDS DE MEXICO; s. de r.l. de c.v.; circuito sur no. 31; mexicali, mexxico c.p. 21395 ; MX 21395
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill avenue; glendora, CA 91740 ; 9096713431
• MDR Report Key: 8557393
• MDR Text Key: 143388806
• Report Number: 2016150-2019-00009
• 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: Dentist
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 205-1909
• Device Lot Number: 091795555,061799338,081765283
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other