MAUDE Adverse Event Report: CARDINAL HEALTH ELECTRODE, ELECTROCARDIOGRAPH

Model Number 31115788(10179619)

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 03/22/2021

Event Type  Injury  

Event Description

When the patient used the ecg monitoring, the contact part of the ecg electrode pad was red, swollen, painful, itching, and local adverse reactions.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ELECTRODE, ELECTROCARDIOGRAPH
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 17532768
• MDR Text Key: 321096770
• Report Number: MW5139675
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 31115788(10179619)
• Device Lot Number: 1512048S7J22
• Patient Sequence Number: 1
• Patient Age: 58 YR