MAUDE Adverse Event Report: PADDLES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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

Patient Problems Itching Sensation (1943); Rash (2033); Skin Disorders (4543); Contact Dermatitis (4546)

Event Date 08/17/2021

Event Type  Injury  

Event Description

Developed a rash/dermatitis on my back approx 2-5 days after a cardioversion procedure.My primary care physician examined my back 8 days after the procedure, on (b)(6) 2021, and told me the pattern of the affected area corresponded to where a paddle used during the procedure was located.I am experiencing patches of dry/scaly/itchy skin on my back and my primary care physician recommended a otc product, benadryl, to resolve the issue.As of this report the treatment plan has just started, without any noticeable improvement in symptoms.Information about the procedure: type: transesophageal ecg with cardioversion date: (b)(6) 2021 location: (b)(6) hospital, (b)(6).Follow-up information pcp physician: dr (b)(6).Diagnosis provided by pcp: dermatitis, caused by adhesive used on the paddle applied to my back for the cardioversion procedure, i do not know the manufacturer of the paddle used during my procedure.Paddle used during a cardioversion procedure.Need to contact hospital to see what they were prescribing at the time of the procedure.Fda safety report id # (b)(4).

• Brand Name: PADDLES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• MDR Report Key: 12385120
• MDR Text Key: 269427557
• Report Number: MW5103582
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 116