MAUDE Adverse Event Report: GAC INTERNATIONAL STAINLESS STEEL GOLD ACCU-FORM ARCHWIRE; WIRE, ORTHODONTIC

Catalog Number 03-XXX-XX

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

No additional information is available at this time.However, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

In this event an attorney reported that an adult orthodontic patient claims to have swallowed an archwire.

• Brand Name: STAINLESS STEEL GOLD ACCU-FORM ARCHWIRE
• Type of Device: WIRE, ORTHODONTIC
• Manufacturer (Section D): GAC INTERNATIONAL; islandia NY
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w.; 221 w. philadelphia st., ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 5008532
• MDR Text Key: 23219743
• Report Number: 2418500-2015-00003
• Device Sequence Number: 1
• Product Code: ECN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Not Applicable
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-XXX-XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other