MAUDE Adverse Event Report: CARDINALHEALTH 200, LLC MEDI-TRACE CADENCE ADULT MULTI-FUNCTIONAL DEFIBRILLATION ELECTRODES; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Catalog Number 22550A

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685)

Event Date 12/29/2023

Event Type  Injury  

Event Description

Patient had bedside transesophageal echocardiography, and was cardioverted twice using 300 j and 360j via automated external defibrillator pads.Post-procedure burning smell noted.Skin prep did not include hair removal in area of pad placement.Upon removal of pads, there was reddened discoloration present.Provider later noted 1st degree burns on trunk and back.

• Brand Name: MEDI-TRACE CADENCE ADULT MULTI-FUNCTIONAL DEFIBRILLATION ELECTRODES
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): CARDINALHEALTH 200, LLC; waukegan IL 60085
• MDR Report Key: 18486263
• MDR Text Key: 332803270
• Report Number: MW5150074
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 22550A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 169 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White