MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL HEALTH PRE-WIRED NEONATAL ELECTRODE

Catalog Number EPP3CR

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Partial thickness (Second Degree) Burn (2694)

Event Type  No Answer Provided  

Event Description

Suspected burn from neonatal leads.Leads were changed 24 hours prior to event date on (b)(6) 2017 ~ 2100.At time of event bedside nurse changed leads to the neolead micro electrodes.Green lead affected.Event (b)(6) 2017 at 2130.Patient site reviewed (b)(6) 2017.Left mid abdomen with intact flat blister circular 1 cm x 1 cm area with this within a faint erythematous circular region tghe size of the electrode.Flat blister appears intact with scant dry exudate.

• Brand Name: CARDINAL HEALTH PRE-WIRED NEONATAL ELECTRODE
• Type of Device: CARDINAL HEALTH PRE-WIRED NEONATAL ELECTRODE
• Manufacturer (Section D): CARDINAL HEALTH; dublin OH 43017
• MDR Report Key: 6735861
• MDR Text Key: 80999810
• Report Number: MW5071141
• Device Sequence Number: 1
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Device Operator: Health Professional
• Device Catalogue Number: EPP3CR
• Device Lot Number: 170206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11 YR