MAUDE Adverse Event Report: CONMED CLEARTRACE

Model Number 1700-010

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076)

Event Date 06/09/2015

Event Type  Injury  

Event Description

I am on 30 day heart monitoring through (b)(6) - provided with clear trace adult ecg electrodes - ref (b)(4).Lot #1502131 and #1502251.Make my skin very itchy and caused rash that broke skin.I have run out of 'clear skin' to place the electrodes.Reported to (b)(6).Applied hydrocortisone.

• Brand Name: CLEARTRACE
• Type of Device: CLEARTRACE
• Manufacturer (Section D): CONMED
• MDR Report Key: 4847529
• MDR Text Key: 5806575
• Report Number: MW5043081
• 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: 06/10/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/28/2017
• Device Model Number: 1700-010
• Device Catalogue Number: (01)00653405063943
• Device Lot Number: 1502131
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2015
• Patient Sequence Number: 1
• Treatment: IBUPROFEN 200; (B)(6); ORAL CONTRACEPTIVE
• Patient Age: 35 YR
• Patient Weight: 72