MAUDE Adverse Event Report: CARDINAL HEALTH ECG REPOSITIONABLE TRANSLUCENT SNAP LEAD; ELECTRODE

Lot Number 17021DG

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 05/07/2017

Event Type  Injury  

Event Description

On return from an mri, the pt complained of pain where two of his four ekg monitoring leads were placed.Two small burns were noted on the pt's left side.Wound care nurse noted two small second degree burns: 1cm(l)x 1cm(w) - left upper anterior shoulder and 1cm(l) x 0.5cm - left lower lateral abdomen.The md ordered silicone foam dressing to be applied, the pt was discharged home as planned with no add'l treatment required.No subsequent treatment related to this event was reported.This pt was admitted via the ed and sent to mri without staff having knowledge of electrodes being in place.Four of the same electrodes were in use on the pt.Burns were only identified on the left side.No prior events reported with the use of this product.The mfr reported this product contains no metal.Diagnosis or reason for use: telemetry monitoring in emergency department.

• Brand Name: ECG REPOSITIONABLE TRANSLUCENT SNAP LEAD
• Type of Device: ELECTRODE
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 7163789
• MDR Text Key: 96482366
• Report Number: MW5074400
• Device Sequence Number: 0
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/10/2020
• Device Lot Number: 17021DG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 81