MAUDE Adverse Event Report: COVIDIEN WET GEL ECG ELECTRODE; ELECTRODE, ELECTROCARDIOGRAPH

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

Patient Problems Bruise/Contusion (1754); Rash (2033); Swelling (2091); Reaction (2414)

Event Date 08/20/2020

Event Type  Injury  

Event Description

Using 3m 2239 hypoallergenic ecg pads.They leave welts, rash, and bruising.Previous pads made by covidien (wet gel type) also caused rashes; which is why i went to the solid gel 3m 2239.Fda safety report id # (b)(4).

• Brand Name: WET GEL ECG ELECTRODE
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10482707
• MDR Text Key: 205494204
• Report Number: MW5096378
• Device Sequence Number: 2
• 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: Patient
• Type of Report: Initial
• Report Date: 08/29/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 91