MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ESOPHAGEAL COMVI STENT; ESOPHAGEAL STENT

Model Number EC1815BH

Device Problem Insufficient Information (3190)

Patient Problem Erythema (1840)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that erythema was noted on the upper arm of the patient 2 hours after the stent placement.Then, metallic allergy was suspected.However, the erythema disappeared next day and then the patient was found not having the metallic allergy.This device has passed dhr normally, and stent has also been implanted without any problems.And the physician was suspected that erythema was caused by metallic allergy in description, but, the erythema disappeared next day.And then, the metallic allergy has not been founded.Therefore, it is assumed that the allergy reaction has occurred temporarily according to the patient's condition.However, it is hard to determine a problem with our medical devices because it cannot be identified about the patient's treatment environment such as patient's using drugs, other medical devices, food ingestion and so on.In addition, it is stated on user's manual, 5.Warnings, "the stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity." in order to prevent these problems, but, no information on metallic allergy has yet been reported to our company.This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.

Event Description

It was reported that erythema was noted on the upper arm of the patient 2 hours after the stent placement.Then, metallic allergy was suspected.However, the erythema disappeared next day, with the patient's condition very well, and then the patient was found not having the metallic allergy.No additional treatment was applied to the patient.There were no patient complications as a result of this event.

• Brand Name: NITI-S ESOPHAGEAL COMVI STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer Contact: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 7760650
• MDR Text Key: 116365588
• Report Number: 3003902943-2018-00019
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/31/2018

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: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: EC1815BH
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• 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): Hospitalization