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

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

It was alleged that the patient managed to break and swallow the damon archwire.The patient passed the archwire naturally and is doing fine to date.

Event Description

Patients swallowed a piece of wire while having damon appliance in the mouth.The piece of wire slipped out of the tube.The patient managed to break it and swallowed it.

Event Description

Patient swallowed a piece of wire while having damon appliance in the mouth.The piece of wire slipped out and the patient managed to break it and swallowed it.

• Brand Name: DAMON WIRE
• Type of Device: WIRE, ORTHODONTIC
• Manufacturer (Section D): ORMCO CORPORATION; 1889 w. mission blvd; pomona CA 91766
• Manufacturer (Section G): SDS DE MEXICO; s. de r.l. de c.v.; circuito sur no. 31; mexicali, 21395 ; MX 21395
• Manufacturer Contact: suzette rampair-johnson ; 1889 w. mission blvd; pomona, CA 91766 ; 9096713431
• MDR Report Key: 8324183
• MDR Text Key: 136301356
• Report Number: 2016150-2019-00004
• Device Sequence Number: 1
• Product Code: DZC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/08/2019
• 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
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other