MAUDE Adverse Event Report: CONMED CORP. CLEAR TRACE ELECTRODES; ELECTRODE, ELECTROSURGICAL

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

Patient Problem Rash (2033)

Event Date 12/15/2018

Event Type  Injury  

Event Description

I developed contact dermatitis from 2 different adhesive products used in the operating room during surgery.One was a tape (hy-tape) used to hold the et tube in place.I got a rash across my whole face below the nose.The other was from a monitor lead.Clear trace, used to defect nerve/muscle fasciculations during surgery.

• Brand Name: CLEAR TRACE ELECTRODES
• Type of Device: ELECTRODE, ELECTROSURGICAL
• Manufacturer (Section D): CONMED CORP.
• MDR Report Key: 8186218
• MDR Text Key: 131324181
• Report Number: MW5082358
• Device Sequence Number: 2
• Product Code: JOS
• 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: 12/18/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 63 YR
• Patient Weight: 58