MAUDE Adverse Event Report: SDS DE MEXICO DAMON CUNITI ARCHWIRE

Catalog Number 205-1909

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

Patient Problem No Code Available (3191)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

It was alleged that two patients swallowed damon cuniti archwire.It was unknown if the archwires passed through naturally.Doctor stated that the patients are doing fine and "their" are no further issues.

Event Description

It was alleged that two patients swallowed the archwires.

Manufacturer Narrative

It was alleged that two patients swallowed damon cuniti archwire.It was unknown if the archwires passed through naturally.Doctor stated that the patients are doing fine and there are no further issues.

Event Description

It was alleged that two patients swallowed the archwires.

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
• Manufacturer (Section G): SDS DE MEXICO; s. de r.l. de c.v.; circuito sur no. 31; mexicali, mexico c.p. 21395 ; MX 21395
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill ave.; glendora, CA 91740 ; 9096713431
• MDR Report Key: 8170184
• MDR Text Key: 130536173
• Report Number: 2016150-2018-00060
• 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,Followup
• Report Date: 04/30/2019

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: Health Professional
• Device Catalogue Number: 205-1909
• Device Lot Number: 091795555,061799338,081765283
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 11/19/2018; 11/16/2018
• Supplement Dates FDA Received: 03/18/2019; 04/30/2019
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other