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

Catalog Number 205-1902

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient had swallowed damon cuniti wire and was in the intestine.The patient passed it naturally and to date is fine.

Event Description

A wire broke in the patients mouth and patient swallowed the wire.

• 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, 21395 ; MX 21395
• Manufacturer Contact: randy knuckles ; 1889 w. mission blvd; pomona, CA 91766 ; 9096713444
• MDR Report Key: 8876437
• MDR Text Key: 153800422
• Report Number: 2016150-2019-00014
• Device Sequence Number: 1
• Product Code: DZC
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 08/08/2019

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: 205-1902
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/08/2019
• 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