MAUDE Adverse Event Report: SDS DE MEXICO CUNITI WIRE; DAMON COPPER NITI WIRE

Catalog Number 210-1905

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

A doctor reported that a patient had swallowed damon cuniti wire and is in the intestine.Upon further information received an update will be sent.

Event Description

Patient swallowed a piece of wire and it is stuck in the patients intestine.

Manufacturer Narrative

The wire passed naturally and the patient is doing fine to date with no further problems.

• Brand Name: CUNITI WIRE
• Type of Device: DAMON COPPER NITI WIRE
• Manufacturer (Section D): SDS DE MEXICO; s. de r.l. c.v.; circuito sur no 31; mexicali, 21395 ; MX 21395
• Manufacturer (Section G): SDS DE MEXICO; s. de r.l. de c.v.; circuito sur no. 31; mexicali, mexico
• Manufacturer Contact: randy knuckles ; 1889 w. mission blvd; pomona, CA 91766 ; 9096713444
• MDR Report Key: 8672042
• MDR Text Key: 147164977
• Report Number: 2016150-2019-00013
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

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: No Information
• Device Catalogue Number: 210-1905
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/08/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other