MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ENTERAL COLONIC UNCOVERED STENT; COLONIC STENT

Model Number CDT1806

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that eruption was found on the patient face after the stent placement, and no problem with stent placed position and no allergy was found on the stent placed position.The medicine for allergy was prescribed and the patient is currently fine.This device has passed dhr normally, and stent has been implanted without any problems.Also, based on the description, which was written that "no allergy was found on the stent placed position.", and "the patient seemed to be susceptible for allergy.", 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 device 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 as follow.Warnings, "the stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity." 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 eruption was found on the patient face after the stent placement.Stent placement was successfully done.There was a possibility of metallic allergy and it was just in case reported.No problem with stent placed position and no allergy was found on the stent placed position.The medicine for allergy was prescribed and the patient is currently fine.The eruption was decreased.The patient seemed to be susceptible for allergy.It is not clear if it was exactly metallic allergy or not at the end.

• Brand Name: NITI-S ENTERAL COLONIC UNCOVERED STENT
• Type of Device: COLONIC 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: 8132140
• MDR Text Key: 129389846
• Report Number: 3003902943-2018-00033
• Device Sequence Number: 1
• Product Code: MQR
• 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: 11/19/2018

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: 08/22/2021
• Device Model Number: CDT1806
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• 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