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

Catalog Number 210-1905

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/13/2019

Event Type  malfunction  

Manufacturer Narrative

A doctor reported to the (b)(6) distributor that he had wire breakage with being swallowed sometimes.No patient injuries.There was no additional information provided but the product was passed naturally.

Event Description

The cuniti wires broke and possibly passed naturally.There were no reportable injuries.

Event Description

The cuniti wire broke and possibly passed naturally.There were no reportable injuries.

• 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, mexico c.p.
• Manufacturer (Section G): SDS DE MEXICO; s. de r.l. de c.v.; circuito sur no. 31; mexicali, mexico 21395 ; MX 21395
• Manufacturer Contact: suzette rampair-johnson ; 1889 w. mission blvd; pomona, CA 91766 ; 9096713431
• MDR Report Key: 8303289
• MDR Text Key: 137005275
• Report Number: 2016150-2019-00003
• 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,Followup
• Report Date: 04/26/2019

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: 01/14/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 01/13/2019
• Supplement Dates FDA Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: No
• 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