MAUDE Adverse Event Report: CARDIO MEDICAL PRODUCTS, INC. CARDIO MEDICAL CARDIO CLEAR DEFIBRILLATOR PADS; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Lot Number Y060920-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Irritation (2076); Swelling (2091); Burn, Thermal (2530)

Event Date 08/14/2020

Event Type  Injury  

Event Description

Patient had a cardioversion using cardio medical product cardio clear defibrillator pads.The patient was shocked with 150 joules, 200 joules and then 200 joules.Immediately after the procedure, the pads were removed.The patient sustained a red, raised outline on his skin.There was a demarcation that outlined the perimeter of the anterior pad.Patient complained of a skin burn at the anterior chest site.Dr examined and requested that silverdene be ordered to the site.Frequency: applied once.Route: cutaneous; atrial fibrillation.

• Brand Name: CARDIO MEDICAL CARDIO CLEAR DEFIBRILLATOR PADS
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): CARDIO MEDICAL PRODUCTS, INC.
• MDR Report Key: 10453870
• MDR Text Key: 204614805
• Report Number: MW5096272
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: Y060920-01
• Was Device Available for Evaluation?: Yes
• 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: 65 YR
• Patient Weight: 110