MAUDE Adverse Event Report: CONMED CLEARTRACE ELECTRODE PADS

Model Number 1700-010

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

Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Burning Sensation (2146)

Event Date 01/07/2016

Event Type  Injury  

Event Description

Used a lifestar act heart monitoring device for 30 days with cleartrace adult ecg electrode pads, 1700-010.After a few days i noticed redness at the attachment site, experienced burning, itching and red marks that have not gone away after 2 weeks after removal.I applied hydrocortisone and it is helping.

• Brand Name: CLEARTRACE ELECTRODE PADS
• Type of Device: CLEARTRACE ELECTRODE PADS
• Manufacturer (Section D): CONMED
• MDR Report Key: 5396770
• MDR Text Key: 37083803
• Report Number: MW5059721
• 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: 01/21/2016

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 Expiration Date: 10/04/2017
• Device Model Number: 1700-010
• Device Lot Number: 201510051
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR