MAUDE Adverse Event Report: CONMED CLEARTRACE ADULT ECG ELECTRODE PAD

Lot Number 201512301, 201601291

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Discharge (2225)

Event Date 05/25/2016

Event Type  Injury  

Event Description

I am using the lifestar act with conmed ecg pads.I have broken out in a rash from the pads.I am experiencing extreme itching in the areas where i have worn the pads and in some cases when i remove the pads, i have what can best be described as road rash with oozing and with very, very slight bleeding sometimes.The ecg pads are from multiple lots and i don't have some of the lot packages, so my lot list is not complete.I reported this incident to (b)(4).I did not report the incident to conmed.

• Brand Name: CLEARTRACE ADULT ECG ELECTRODE PAD
• Type of Device: CLEARTRACE ADULT ECG ELECTRODE PAD
• Manufacturer (Section D): CONMED
• MDR Report Key: 5705918
• MDR Text Key: 46852814
• Report Number: MW5062724
• Device Sequence Number: 1
• Product Code: DRX
• 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: 06/03/2016

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?: No
• Device Operator: No Information
• Device Lot Number: 201512301, 201601291
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 75